clinical research organization definition

2024: An Endeavor into the Enigma - Uncovering the Substance of CROs

Reflecting on the complexities inherent in the acronyms CRO (Clinical Research Organization) and CRA (Clinical Research Associate) indeed reveals a multifaceted landscape within the realm of clinical research. For those deeply entrenched in the nuances of clinical inquiry, understanding the operational mechanisms of CROs emerges as a pivotal journey delving into the uncharted territories of healthcare advancement. Whether venturing into the realms of clinical research for the first time or seeking a renewed perspective, delving into the semantic intricacies of CROs and unlocking their transformative potential in healthcare becomes an essential exploration, propelling organizations towards unparalleled developmental heights.

The Essence of a CRO:

Clinical Research Organizations, abbreviated as CROs, epitomize entities entrusted with the management of clinical trials on behalf of pharmaceutical and biotechnological giants. Their mandates encompass the selection of patients, procurement of informed consent, aggregation of data, and the persistent oversight of safety protocols. CROs are broadly categorized into two overarching classifications: full-service CROs, offering a spectrum of services essential for clinical trials, and specialized CROs, focusing their expertise on specific areas such as patient enrollment or data management.

The Era of CRO Dominance:

A seismic shift characterizes the ascendancy of CROs in recent chronicles. The tally of clinical trials orchestrated by CROs surged from 9,000 in 2006 to a staggering 26,000 in 2016. This remarkable ascent fundamentally attributes itself to the accessible expertise and efficiency that CROs demonstrate, all at a cost-effective rate compared to traditional avenues of research. Moreover, the integration of CROs into the operational framework enables pharmaceutical and biotechnological entities to sharpen their core competencies while concurrently mitigating the looming specter of clinical setbacks.

Navigating the Intersection of Costs and Benefits:

However, amidst the commendable merits inherent in CRO engagement, a caveat looms ominously. Skepticism burgeons regarding the equivalence of expertise, with concerns revolving around the potential discrepancy in data quality vis-à-vis conventional research entities. A lingering unease surfaces, questioning the parity of commitment to patient safety between CROs and their traditional counterparts. Navigating through the intricate labyrinth of CRO utilization necessitates a judicious assessment, a meticulous weighing of the benefits against the potential pitfalls in the steadfast pursuit of advancing the uncharted territories of healthcare improvement.

Clinical investigate organizations, recognized as contract inquire about substances, expand outsourced administrations to the pharmaceutical and biotechnology divisions. These organizations organize clinical trials for inventive pharmaceuticals and restorative approaches. The engagement of CROs can be started either by the pharmaceutical companies themselves or by the scholastic teach initiating the trials. The CRO industry has been encountering exponential development in later a long time. In 2024, the worldwide CRO administrations showcase gathered an evaluated $25.1 billion in 2024, with projections showing a compound yearly development rate of 7.5% over the resulting five a long time. Clinical inquire about administrations constituted the most considerable share of this advertise, measuring to $19.8 billion in 2024. Multiple variables contribute to the thriving of the CRO industry. At first, there has been a essential surge in the around the world conduct of clinical trials. Hence, a move from minute, casual trials to sweeping, formal trials overseen by commercial CROs has been watched. Thirdly, there is a recognizable uptick in the outsourcing slant among pharmaceutical and biotechnology enterprises. The essential on-screen characters in the CRO division include major multinational substances such as QuintilesIMS, Covance, and Parexel. At the same time, an developing unexpected of littler CROs specializes in specific restorative spaces or particular trial categories, extending the industry's scope and diversity. So, what absolutely constitutes the modus operandi of a CRO in 2024? In pith, a CRO outfits a comprehensive cluster of administrations including consider conceptualization, ponder execution, watchfulness, information administration, and expository interests. Furthermore, they habitually apportion administrative backing administrations like creating entries and conducting administrative audits. The vital advantage of locks in a CRO dwells in its capacity to speed up the medicate advancement direction. By subcontracting select or whole clinical trial endeavors, pharmaceutical enterprises in 2024 stand to abridge consumptions and rescue time. CROs, blessed with capability in executing clinical trials, adeptly encourage effective and compelling trial executions, subsequently progressing the field of pharmaceutical investigate.

What are the benefits of Clinical Research Organizations?

There are many benefits to working with a Clinical Research Organization (CRO). Perhaps the most important benefit is that CROs can help you to move your clinical research program forward faster and more efficiently. They have the experience and expertise to help you manage all aspects of your study, from start to finish. This can save you a lot of time and money, as CROs know how to navigate the complex world of clinical research.

Another major benefit of using a CRO is that they can help you to reduce risk. By using their experience and knowledge, CROs can help you to select the right study participants, design the study correctly, and implement best practices throughout the study. This can help to minimize any potential risks involved in conducting your study.

Finally, CROs can also help sponsors save money. They have established relationships with vendors and suppliers, so they can often get better deals on study materials and services than you would be able to negotiate on your own. This can result in significant cost savings for your clinical research program.

What are the challenges of Clinical Research Organizations?

The burgeoning domain of Clinical Investigate Organizations (CROs) experiences a heap of challenges in the year 2024. The quick development of this industry applies colossal weight on CROs to speed up and streamline considers, frequently coming about in hurried and substandard work. Concurrently, the basic to reduce costs holds on, coupled with the heightening complexities of administrative orders. Besides, hooking with furious competition from financially beneficial countries includes an extra layer of complexity, given their capacity to give cost-effective services.

These multifaceted challenges have accelerated various misgivings with respect to the quality and security guidelines inside the CRO space. A chronicled occasion in 2013 seen the FDA issuing a cautionary note to a CRO locked in in sedate company considers. The reprobation highlighted different deficiencies in the CRO's endeavors, including insufficient consider plan, subpar information administration, and a shortage of satisfactory observing protocols.

In a more later occurrence, circa 2013, another FDA caution resulted, provoked by a quiet casualty amid a clinical trial conducted by a CRO. The administrative body perceived insufficiencies in the CRO's oversight, showing in an insulant checked ponder and the disappointment to report grave antagonistic events.

These outlines only scratch the surface of the horde security worries that have tormented the CRO scene all through the a long time. The need of exacting quality control measures and inadequately observation can possibly result in extreme wounds or indeed fatalities for people taking an interest in clinical trials. Tending to these security concerns orders a concerted exertion. The FDA has spread direction archives and administrative goals pointed at improving the caliber of CRO endeavors. At the same time, pharmaceutical substances must work out increased acumen in selecting capable CROs whereas giving persevering oversight. Planned patients are empowered to attempt exhaustive investigate some time recently enlisting in clinical trials and ought to posture related inquiries with respect to the trial's procedural conduct.

Innovative Approaches to Better Clinical Research Organizations in the Year 2024

In the scene of clinical investigate organizations (CROs) as of 2024, there is a essential require for upgrade to guarantee the viability of clinical trials. The necessarily part of CROs in the arranging, execution, and documentation of clinical inquire about thinks about requires a sharp center on advancement strategies.

To move the advancement of CROs in 2024, one vital road includes the outsourcing of clinical inquire about preparing. By entrusting this pivotal viewpoint to outside substances, CROs can ensure comprehensive preparing in best hones, cultivating the conveyance of trials of the most elevated quality. This approach too serves to keep CROs side by side of cutting-edge advances and winning patterns inside the field, contributing to their ceaseless refinement.

Another essential road for the upgrade of CROs lies in the enlargement of straightforwardness. This means the basic of making operational subtle elements of CROs freely open. Such straightforwardness envelops illustrating the strategies utilized by CROs, uncovering the results of their considers, and uncovering the charge structures they execute. By grasping straightforwardness, the moral operation of CROs is shielded, guaranteeing impartial treatment of patients.

In the broader setting, the change of CROs in 2024 is a multifaceted endeavor. Outsourcing clinical inquire about preparing and cultivating straightforwardness rise as linchpin procedures to accomplish this overarching objective.

While CROs irrefutably constitute a significant aspect of the clinical inquire about prepare, their adequacy pivots on tending to characteristic challenges. Moved forward communication and straightforwardness with supports, destinations, and patients are basic for CRO viability. Emphasizing quality over amount is vital to maintain a sterling notoriety inside the industry. If diving more profound into the complexities of clinical investigate organizations interests you, consider selecting in our clinical inquire about certification course for an smart investigation of their working.

A Comprehensive Guide to PMP Certification

The meaning of triage: a guide for the clinical research professional.

What is a contract research organization (CRO)?

Clinical trial services.

What does a CRO do?

CROs are hired by sponsors who want to run a clinical trial. This eliminates the need to hire full time staff to complete the project and provides an opportunity to work with the CRO on a project-by-project basis. The CRO is hired to plan, coordinate, execute, and manage the lifecycle of the clinical trial, safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians, and research coordinators.

What does a CRO mean in clinical trials?

CROs have the knowledge, capabilities, processes and procedures that are needed to develop and run a successful clinical trial, while ensuring trial quality and compliance with national and international standards. Working with a contract research organization can offer innovative tools that can increase efficiencies, leading to decreased timelines and cost. Choosing the right CRO to run your clinical trial is crucial to the trial success. In addition to consideration of their own project needs, requirements, and budget when selecting a CRO, Sponsors should evaluate the qualification, experience, and quality system processes of the CRO.

Our CRO services

MED Institute is a full service contract research organization with over 35 years of experience designing and executing clinical trials, ranging from early feasibility studies  to multinational, controlled pivotal trials to post-market registries. Our clinical trial services include clinical trial planning, clinical data management, clinical project management, and clinical trial monitoring.  Our MED team is able to support your clinical study from start to finish or is able to help with one specific aspect of the clinical study (e.g., monitoring).

Clinical trial planning and study start-up include the process of creating the clinical plan and clinical protocol and obtaining the necessary approvals from regulatory authorities and ethics committees. We can help you design a clinical study tailored to your product’s specific needs, to collect data efficiently while meeting all regulatory requirements. Our protocol development process involves working in collaboration with clinical experts and other study stakeholders to identify reasonable performance goals, to determine appropriate examinations and procedures, and to define the right patient population. It ensures the clinical study protocol will successfully implement the study plan and maintain compliance with all applicable regulatory requirements. A well-written protocol is essential to maximizing efficiency and minimizing risks in gathering the necessary clinical data for your product.

Clinical data management is critical to the clinical trial process. We are dedicated to providing high quality clinical data management services to support your product development needs, obtaining clinical trial data you can trust to save time and resources. We can create case report forms (CRFs) that ask the right questions to achieve your clinical trial’s goals in a simple and intuitive way. These CRFs are customized to suit the project type and individual requirements for streamlined data entry, avoiding the unnecessary delays and potentially inaccurate data that often result from poorly designed CRFs.  We can generate paper or electronic CRFs based on the clinical trial and Sponsor requirements.

Drawing from our experiences working with hundreds of investigators worldwide, we are able to build efficient, intuitive electronic data capture (EDC) systems that are simple for investigators to learn and use. The benefits of a well-designed, well-built EDC system contribute to minimizing the time and cost to run a clinical trial. Learn more about designing and building an EDC system in our “Considerations for designing and building an electronic data capture (EDC) system” blog series-  Part 1: with users in mind  and  Part 2: with sponsors/CRO in mind .

Clinical project management is important to ensure that your trial runs as smoothly as possible. Our clinical project management team has decades of experience managing trials ranging from first-in-human proof of concept to multinational, multicenter, controlled pivotal trials. We emphasize efficiency in conducting clinical trials, while maintaining exemplary quality and compliance. Our team can complete clinical site assessments, help you prepare documentation for IRB/Ethics Committees, complete the site initiation and training, and complete the necessary steps for trial closeout. Our experience with a multitude of trial sites around the world has taught us how to evaluate potential sites, and the right questions to ask to determine the best fit for each clinical trial. We also strive to see that candidate sites learn enough about the requirements of the clinical trial to determine whether it is a good fit for them. Smart site selection contributes greatly to completing a clinical trial on time and on budget.

Clinical trial monitoring helps ensure that the trial is conducted, recorded, and reported in accordance to the protocol, ethics committees, and Good Clinical Practice (GCP) . We create comprehensive, but efficient, monitoring plans to manage clinical trials and engender confidence in clinical trial integrity. Analytics are used to implement a risk-based approach to monitoring, which reduces costs without sacrificing assurance of data reliability, investigator compliance, or meeting regulatory reporting obligations. Active clinical monitoring can help predict potential clinical trial challenges or at least identify issues early so they may be addressed before they lead to significant delays leading to increased costs, or derail the trial completely.

How to choose a good contract research organization

Choosing a good CRO is very important and contributes to the success of the study and helps the trial to run as smoothly as possible. Some of the questions to ask when choosing a CRO are:

• Do they have an established quality system, with procedures to address the assigned clinical study activities?
• Are they responsive and willing to work with you and communicate throughout the project?
• Do they have stable project teams is there high turnover?
• Can they assist with data management?
• Will they help you recruit and manage safety boards or committees?
• Will they be able to conduct audits to help you prepare to pass BIMO FDA inspections ?
• Can they provide general site support and project management help in addition to clinical monitoring?

CROs are hired by Sponsors who want to run a clinical trial and become a fundamental part of the trial. They offer a wide variety of services associated with conducting the study from start to finish. It is important to choose a good CRO as the success of your trial is dependent on the management and capabilities of the CRO.

We can partner with you to successfully take your clinical trial from start-up to trial close out. Contact us today to discuss your clinical trial needs 855.463.1633 | [email protected] | medinstitute.com.

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Clinical Research Organization (CRO): How they work?

• Author Company: Clariwell Global Services
• Author Name: Zain Malik
• Author Email: [email protected]
• Author Telephone: +917709551477
• Author Website: https://www.clariwell.in/best-clinical-research-courses-in-pune-with-100-percent-job-guarantee

A clinical research organization (CRO) is often called a contract research organization (CRO). CRO is a service organization that provides support to pharmaceutical and biotechnology industries in the form of outsourced clinical research courses and services for both medical devices and drugs.

The main functions required to conduct clinical researches, which are usually departments of the clinical research organization, are:

• The function of medical operations: People working in this area are given clinical research training from various clinical research institutes. This sector includes medically qualified people who are capable of constructing and designing clinical studies, clinical trials, and their protocols to provide medical-related input throughout the study. This includes roles like medical monitor, clinical research physician, advisors, etc.
• Clinical operations: This is the most organized and the largest team in any contract research organization. It consists of medical research associates, clinical trial assistants, managers, etc. This is the team of the CRO, which selects the clinical trial sites and locations, assists the studies, monitors the studies, etc.
• Data Management: This team helps in managing and designing various tools and databases. This is done in order to collect data from the trial. They help in ensuring that the data collected from the trials is accurate and is suitable for analysis. To keep track and organized, this team uses sophisticated software and modern technologies.
• Biostatistics: This team plays a major role in the outcome of the trial. They help in analyzing the study data and figuring out whether the study has yielded positive results or negative results while adhering strictly to all the protocols. They also generate statistical tables, figures, and graphs with their interpretations which are all then passed down to the medical writers to compile into reports.
• Writing team: these writers compile all the data into medical reports that can easily be understood by the public as well. They also manage the study protocols, study analysis reports, promotional material, etc.
• Quality assurance: The audits to ensure that the guidelines, standard operations, and regulation procedures are followed throughout are assessed by these trained professionals. This department is entirely dedicated to ensuring the quality of the product.
• Human Resources: Every clinical research organization has a dedicated human resource organization that is responsible for hiring trained professionals for various job roles and positions within the organization. They have to maintain a certain level of talent in the talent pool available.
• IT team: This is generally considered to be the support staff of the Clinical research organizations. They take care of all the IT-related needs like maintenance and purchases of laptops, desktops, telephones, software, etc.
• The finance team: All the monetary controls and the finance part, including the administration of the whole CRO, is managed by this department of the CRO.
• Training and Development: This is a dedicated department to training and developing in the CRO. It focuses on the professional development of all its employees and conducts routine training to make sure that their staffs remain up to date with all the developments in technology. It acts as a clinical research institute that provides the best clinical research courses and clinical research training .

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What Is a CRO?

Pharmaceutical, biotechnology and medical device companies initiate, manage and fund clinical trials and are ultimately responsible for the clinical trial process. They are referred to as sponsors. Clinical trial sponsors also include government agencies, such as the National Institutes of Health (NIH) in the United States, and non-profit organizations.

The research and development process for a single drug can require the participation of thousands of people. It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion. It is a long, complex and expensive process, and many sponsors are not equipped, resourced or prepared to perform all trial-related duties and functions themselves.

For this reason, sponsors may choose to outsource all or part of the trial-related tasks to a company called a clinical research organization or contract research organization (CRO) to manage the clinical trial on their behalf, without sponsors having to maintain a staff for these services. CROs have the capacity to conduct the day-to-day research activities that are either not possible or too expensive for a sponsor to achieve in-house. CROs are experts in the space and active partners in clinical research.

• A CRO's Role in Pharmaceutical Development
• Functions of a CRO
• Clinical Research and Trial Management
• Global and Specialized CRO Services

“ It may take as long as 15 years to bring a new drug to market and the average cost can exceed $1 billion . “

CROs in the United States

the size that the global CRO market size is expected to reach, in dollars, in 2023

What Is a CRO’s role in pharmaceutical development?

CROs play a major role in ensuring safe, ethical clinical trials that are essential to developing new, life-changing drugs and medical devices that benefit millions of patients worldwide .

The services that a CRO may offer can cover the full timeline of the study:

• The development and revision of protocols for trials
• The adaptation of the necessary documentation to the applicable rules
• Obtaining the necessary approvals from clinical research ethics committees and regulatory authorities
• The design and preparation of case report forms
• The determination of the sample
• The selection of the best researchers and research centers
• The final negotiation of the contracts among all parties (the CRO, vendors and sites).
• Once regulatory approval is obtained and the trial begins with site selection and patient recruitment, the CRO can provide monitoring , which consists of controlling compliance with the protocol and the procedures established for the development of the study. Likewise, pharmacovigilance services include detection and action in case of any adverse event (AE).
• The last steps to ensure the success of any clinical study are the statistical analysis and management of the trial data , the generation of reports (including the clinical study report for submission to regulatory authorities for drug approval) and the control and storage of the documentation.

CRO structure

A Contract Research Organization (CRO) acts as a bridge between the sponsor, the one who contracts the services, and the rest of the actors involved in the clinical trial.

(Leon Research, https://leonresearch.com/what-is-a-cro-and-how-can-it-help-you-in-your-clinical-trial/ )

Functions of a Clinical Research Organization

Typically, a CRO provides scientific, clinical and business continuity for clinical trial sponsors. The CRO can be involved in a range of services from pre-clinical research (which takes place before human trials) to post-marketing surveillance (which takes place after a product has been approved for use).

Other administrative activities may include strategic consulting and protocol development, laboratory and analytical services, project management, trial logistics, medicine and disease coding, statistical analysis and reporting, validation programming, safety and efficacy summaries and the final study report.

Clinical research and trial management

A sponsor hires a CRO to plan, coordinate, execute and manage the life cycle of the clinical trial safely and efficiently. Serving as the main contact between the sponsor and other stakeholders throughout the trial, the CRO communicates with ethics and compliance committees, regulatory personnel, vendors, physicians and research coordinators.

Clinical trials conducted by CROs are completed on average 30 days faster than those conducted by sponsor companies. 1

Every day counts for both patients (who may be anxiously waiting on therapies that could improve or even save their lives) and sponsors (because time spent in the development process counts against the patent protection period after the drug goes to market, affecting sales revenue).

With more than 35 years of experience, the PPD clinical research business of Thermo Fisher Scientific offers an established drug development platform, patient enrollment expertise and robust laboratory services . Our broad range of clinical development, analytical and patient and advisory services – including full service to functional service provider services , digital and decentralized trials, and laboratories – enables customers to drive innovation and increase drug development productivity. We are recognized for accelerating promising medicines from early development through regulatory approval and market access. Our flexible, custom-tailored solutions serve pharmaceutical, biotech, medical device, academic, government and public health organizations in clinical research and development .

Global and specialized CRO services

Most large CROs are full-service, providing complete clinical trial management support, but there are some companies specializing in a specific type of study (e.g., research with medical devices or observational studies) and also CROs specializing in a specific therapeutic area, such as oncology or ophthalmology.

Global CROs, large companies with operations all over the world, provide greater, integrated geographical coverage, with more service offerings and capabilities, while local companies may sometimes have more in-depth knowledge of a particular country’s nuances and demographics as they relate to clinical development.

The global network consisting of clinical sites within the PPD clinical research business of Thermo Fisher Scientific and non-owned partner sites offers access to a diverse pool of healthy volunteers and specialty populations around the world. Our experienced staff provides external oversight of a trial, working directly with the institutions where clinical studies are conducted – hospitals and clinics, called investigational sites. We provide training to the principal investigator and the site staff, and ensure that the safety, rights and well-being of patients are protected; that the conduct of the trial is in compliance with regulatory requirements; and that reported trial data are accurate and complete.

What is the difference between a CRO and a sponsor?

Although the sponsoring company may transfer the trial functions to a CRO, the sponsor owns the investigational product and needs to ensure results are factual and scientifically backed. 

According to the definition of the International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) , a CRO is: “A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions.” 

The sponsor maintains a central role throughout the clinical trial process. Although regulatory tasks differ globally, they include initiating the trial process by submitting an application and ensuring approval is obtained (directly or indirectly).

The ICH Guideline for GCP specifies the responsibilities a CRO can take over from a sponsor : 

• 5.2.1: A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
• 5.2.2: Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor’s contracted CRO(s).
• 5.2.3: Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
• 5.2.4: All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.

What are the advantages of outsourcing to a CRO?

A CRO can offer substantial cost savings for a sponsor by reducing the time it takes to conduct a trial compared to a sponsor doing so in-house. This also eliminates the need for staff, infrastructure and lab and office space for the sponsor to run the trials themselves. Finally, a full-service CRO can provide access to a global network of clinical research sites, meaning it can quickly identify suitable sites for clinical trials in multiple countries. Geographical reach or therapeutic focus can be important in patient recruitment, especially in specific populations, such as underserved and diverse , or for rare diseases that affect a small subset of people.

Working with a CRO gives sponsors access to the most advanced technology and systems for data management, product development, research analysis and other clinical research services. CROs are quick to adopt the latest technologies, enabling them to provide strategic insights and advice, and to offer novel and distinctive ways to use advanced tools and adapt them to each sponsor’s needs to ensure optimal clinical trial performance. Given that CROs work with many different sponsors, they often have a breadth of experience beyond even a single large pharmaceutical company.

CROs adhere to clinical compliance on a daily basis, which requires intricate in-house knowledge of regulatory requirements and audits such as GCP (Good Clinical Practice) or GLP (Good Laboratory Practice) audits.

Sponsors conducting clinical research in a niche area such as rare disease may choose to work with a specialty CRO or a global CRO with offering such services.

Global Network

The PPD clinical research business of Thermo Fisher Scientific has an extensive global network of investigators, clinicians and partners with a wide range of products, technologies and services that can be leveraged for clinical trial conduct. Our goal is to deliver considerable time and cost savings in drug development, critical to accelerating the delivery of life-changing therapies. Our experts consider the end before the beginning by envisioning and planning for commercialization and market acceptance well before the first patient is enrolled in a clinical trial. And before trials are underway, we design for post-approval, real-world patient observation that provides support for payer authorizations and may lead to new ideas and products .

How does a sponsor select a CRO?

When selecting a CRO, here are some questions to consider:

• Can the CRO offer the services that the sponsor needs?
• Does the CRO have related experience and a good track record (i.e., similar projects and references or testimonials from satisfied clients)?
• Is the CRO financially stable?
• Does the CRO have a good system for employee training and a low staff turnover rate?
• Does the CRO have the key staff members required and can it set up a team to deliver qualified results?
• Does the CRO have the required infrastructure?
• Does the CRO have a robust quality assurance system?
• Is the CRO’s team responsive and willing to work with you and communicate throughout the project?
• Does the CRO have specialty services, laboratories, digital and decentralized solutions, a clinical supplies network and other capabilities important to your drug development program?
• Will the CRO help you recruit and manage safety boards or committees?
• Will the CRO conduct audits to help you prepare to pass FDA inspections?
• Can the CRO provide general site support and project management help in addition to clinical monitoring?
• Does the CRO function as a vendor or a true partner ?

Drive your drug development program forward

Partner with a leading, global CRO that leverages a proven track record and deep expertise to keep the patient at the forefront of your trial.

The PPD clinical research business of Thermo Fisher Scientific accelerates your success with a dynamic, forward-thinking approach, a comprehensive suite of capabilities and true partnership with our customers.

• Investigators
• Clinical Data Management
• Medical Device CRO

Selecting a CRO

WHAT IS A CRO?

• Request for Proposal

What is a Contract Research Organization?

A Contract Research Organization (CRO), sometimes known as a Clinical Research Organization, is an organization contracted by another company to take the lead in managing that company’s trials and complex medical testing responsibilities. Contract Research Organizations reduce the cost of research and development to help businesses and institutions meet the needs of the evolving medical device and pharma industry.

Topics covered below:

• What is Clinical Outsourcing?
• What Does a Contract Research Organization Do?

Benefits of Outsourcing to a CRO

• Working With a CRO
• Contract Research and Manufacturing Services (CRAMS)

What Is Clinical Outsourcing?

Clinical outsourcing occurs when a company hires another company made up of researchers and experts to conduct comprehensive and complex medical research so that the hiring company does not have to staff experts in-house, or maintain the required infrastructure and office space. This enables the hiring company to receive expert medical testing while also saving both time and money.

To reduce the cost of research and development, drug companies are increasingly outsourcing their medical testing responsibilities to alleviate the growing and ongoing cost of maintaining medical facilities and full-time staff year-round.

What Does A Contract Research Organization Do?

Contract Research Organizations (CROs) conduct clinical trials and research support services for biotechnology, medical device, and pharmaceutical industries, as well as universities, government organizations, and foundations.

CROs are able to provide a wide range of clinical research services to medical sponsors, including, but not limited to:

• Procedures and Logistics
• Resource Allocation Management
• Database Design
• Data Entry and Validation
• Database Maintenance and Archival
• Security Procedures
• Site Recruitment
• Patient Recruitment
• Study Monitoring
• Site Management
• Audits/FDA inspection support
• Clinical SOP Development
• GCP Seminars
• Medicine and Disease Coding
• Validation Programming
• Market Assessments
• Market Research
• Strategic Planning Consultation
• Medical Product Registration
• Product Launch
• Product Marketing
• Product Sales
• Safety and Efficacy Summaries
• Quality Reporting
• Statistical Methodology Consultation
• Statistical Analysis Plan Development
• Statistical Analysis Reports
• Final Study Reports
• Clinical Study Protocol Documents
• “Instructions for Use”
• Manuscripts
• PowerPoint Presentations
• White Papers

Outsourcing to a Contract Research Organization can bring multiple benefits to clinical professionals and institutions.

When choosing to outsource clinical work, consider:

Time Savings

Cost Savings

Advanced Technological Needs

Evolving and Complex Regulatory Requirements

Outsourcing to a CRO saves critical time in the trial and development phase. Working with a CRO to conduct a trial often significantly reduces the time it takes compared to completing the trial in-house. CROs are already set up with all of the necessary tools and resources needed as well as a team of in-house experts who are experienced in all areas of clinical testing, development, and compliance.

There are significant cost savings in hiring a CRO. A faster trial process alone offers medical institutions a reduction in costs. There are also financial savings in each long-term purchase an entity would incur in order to run sufficient research trials. Full-time staff and medical facilities are costly year-round, especially when they are not needed during all parts of the year.

Working with a CRO gives hiring companies access to the most advanced technology and systems for data management, product development, research analysis, and other clinical research services. Clinical research is a rapidly changing industry. It is essential that software and hardware IT capabilities, as well as Internet-based applications, are the best in the industry to facilitate the acceleration of clinical trials while maintaining comprehensive quality control.

The FDA and other relevant regulatory authorities require intricate and accurate data for approvals. CROs work within clinical compliance on a daily basis, which gives them intricate knowledge of regulatory requirements and audits such as Good Clinical Practice (GCP) audits or Good Laboratory Practice (GLP) audits. CROs work with hiring companies to optimize audit results through careful review of any previous issues, close inspection of infrastructure, and adherence to current protocols.

Working with a CRO

There is a wide variety in CROs. Some are large, publicly owned companies with global coverage and a range of comprehensive services, while other CROs are small, privately owned companies that specialize in a specific niche area. Comparing one CRO to another can be very difficult, as CRO budgets and services often vary significantly from one company to the next. When selecting a CRO, take into account the company’s previous experience, including the types of projects completed, the clients they have worked with, any niche services they provide, as well as their overall track record in the industry.

Before you decide, read our guide on how to efficiently and effectively evaluate Clinical Research Companies and download our CRO Evaluation Checklist .

Sponsor’s Responsibility

A business, organization, or institution may transfer any or all of their clinical trials and research responsibilities over to a Contract Research Organization, but the responsibility remains with the original company hiring the CRO. The quality and integrity of the clinical research data continue to reside with the entity sponsoring the work. CROs should be backed by a spotless track record of quality assurance and quality control.

Get It In Writing

When hiring a CRO, always ensure each delegated task is outlined in writing and signed by both parties. All agreements should be thoroughly documented by all of the involved parties to avoid any costly misunderstandings or complications. It should be very clear which organization is responsible for each aspect of the medical research, development, or other clinical services. Any services or components that are not specified in the agreement will remain the responsibility of the hiring entity.

What Is Contract Research And Manufacturing Services?

Contract Research and Manufacturing Services (CRAMS) is a broader clinical outsourcing term that includes CROs as well as CMOs, Contract Manufacturing Organizations.

Contract Manufacturing Organizations (CMOs) are similar to CROs, in that they are also hired by another pharmaceutical company on a contract basis. The purview of a CMO is in the development of a drug through to its manufacturing.

They all make up a rapidly expanding segment of the biotechnological and pharmaceutical industry. Outsourcing specialized clinical research and manufacturing work continues to develop as organizations aim to meet the needs of an evolving industry.

Promedica Intl. (PMI) delivers the quality and consistent results of a large Clinical Research Organization with the efficiencies and responsiveness of a small CRO. PMI can support your needs with a range of specialized services, including Project Management, Product Development Planning, Clinical Study Management, Product Commercialization, Medical Writing, Biostatistics, Data Management, and Research Compliance & Education. 

Learn more about our wide range of clinical services , contact our team , or submit a Request for Proposal .

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Home » Digital Adoption » What Is A CRO? The Pharmaceutical, Biotechnology, and Healthcare Device Industries Explained

What Is A CRO? The Pharmaceutical, Biotechnology, and Healthcare Device Industries Explained

• Updated February 9, 2023

This article will explain what a CRO is, an acronym for Clinical Research Organization or Contract Research Organization. Anyone involved in healthcare-related industries will have some experience working with these outsourcing companies that deal in clinical trials.

After all, medical outsourcing is a huge industry. A 2022 Fortune report predicted that the industry will be US$90 Billion by 2026. Companies across the pharmaceutical industry seek to reduce costs and improve outcomes, making it more critical than ever to consider the most efficient way to conduct clinical trials.

The healthcare industry is on a mass digital adoption spree, and outsourcing clinical trials has become a viable option with the assistance of new technology such as blockchain, AI, and cloud storage. These new technologies have allowed companies to reduce costs and increase efficiency in their clinical trials by streamlining processes and creating a secure platform for data exchange.

However, choosing a CRO can be a complex process. This article will explain what a CRO is, how they can support major companies and the criteria for selecting the right CRO.

What Is A Contract Research Organization (CRO)?

A CRO is an organization that undertakes short-term contracts in research and development across the life sciences industries. CROs are especially valuable in medical sectors, including pharmaceutical companies, biotechnology, and medical technology.

They support efficiency by staying up-to-date in all aspects of R&D. The contracting company does not need to maintain their research experts or provide the infrastructure for them to work.

The acronym CRO usually refers to a “contract research organization,” but this is synonymous with “clinical research organization.”

Contract research organizations choose to specialize their services in different ways. Some will provide services to one particular niche or industry. Others may specialize in a specific kind of medical research.

How a Clinical Research Organization Can Support the Clinical Trial Process

Clinical trials are complicated, expensive, and time-consuming. Even the largest pharmaceutical company won’t always have the research and development capacity to complete successful trials internally.

A contract research organization can support companies by taking charge of all trial-related duties. In doing so, CROs ensure oversight of the quality assurance process in a cost-effective way.

A successful trial relies on a tight network of specialist medical staff, reliable participants, and regulatory knowledge and involves manufacturers, sponsors, and moral authorities. Moreover, valuable trial data depends on outstanding quality at every step of the process.

Companies dealing with drug development, medical devices, or biotechnology require extensive clinical trials to guarantee that their products are thoroughly tested and ready to market. CROs efficiently provide the peace of mind that only comes with thorough research and documentation.

In an increasingly digital world, communications between CROs and their sponsors often benefit from digital transformation. On the consumer side of healthcare, digital adoption has been shown to improve customer experiences. Digital adoption solutions can likewise integrate companies seamlessly.

What Are The Benefits Of CROs?

Many benefits of business process outsourcing medical trials are similar to other kinds of outsourcing. A CRO helps a company to access specialized staff, manage financial constraints, and tailor solutions that match their needs.

However, the specific demands of trial logistics mean that there are some more specific benefits of contracting with a CRO:

Enhanced Quality Assurance

The CRO looks after a vast range of assurance responsibilities that lead to a consistently high trial quality.

A CRO has the right research staff, innovation knowledge, and physical capabilities to conduct an excellent trial from start to finish. From clinical monitoring and site selection to medical writing, the CRO does vital work in ensuring trial quality.

Better Regulatory Compliance

Regulatory authorities of all sizes govern clinical trials with non-negotiable policies and legally binding rules. Many organizations would struggle to keep up with the most relevant compliance issues. However, the specific regulatory requirements in an industry are a fundamental part of the CRO’s work.

Aligned With Good Clinical Practices (GCPs)

The UK government explains that Good Clinical Practice is “a set of internationally-recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting clinical trials that involve people.”

These requirements place a necessary burden on trial sites to report problems and accept inspections. In other words, maintaining a trial center is much more than allocating the right office space for the job. CROs do a lot of work to keep their centers ready for inspections at all times.

What Clinical Trial Management Services Do CROs Offer?

A CRO can support all stages of the planning, execution, and review of a clinical trial. A business leader can hand over all of the sponsor’s trial-related duties to the CRO if necessary.

However, many CROS can support sponsors with just one or more aspects of functions carried out in the trial process. Some of the typical CRO services that businesses can use include the following. 

Clinical Study Design

The design stage is the moment for the CRO to find a solution that meets the sponsor’s needs. They will advise on the best type of approach, the type of participants, the budget, and the schedule. 

Success Metrics

The planning team at a CRO will be able to advise on the most reliable measures of success. This is an excellent stage for dialogue between the sponsoring organization and the contract research organization itself.

Protocol Assistance

CROs deal with the details of trial protocols every day of the week. They are best placed to rigorously monitor documentation around ethics and regulatory affairs, ensuring that national and international standards are kept.

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Clinical Research Organizations

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Part of the book series: Pediatric Oncology ((PEDIATRICO))

Contract research organizations, also known as clinical research organizations (CROs) or contract service organizations (CSO), or pharmaceutical development organizations, are established businesses that collaborate with pharmaceutical or medical device companies to assist them in the clinical development of their medication or device. While the sponsor retains responsibility for the conduct of the trial, CROs provide essential support services that may include regulatory affairs, regulatory submissions, budget generation, data management, biostatistics, medical monitoring, clinical monitoring, medical writing, and project management. CROs facilitate drug and medical device development by operationalizing clinical trials in accordance with Good Clinical Practice (GCP) guidelines, relying on their expertise in clinical trial conduct, operations experience, and close relationships with sites and investigators.

• Contract research organization
• Clinical research organization
• Clinical trial
• Data management
• Clinical monitoring
• Regulatory affairs
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A Comprehensive Guide to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) play a crucial role in the pharmaceutical, biotechnology, and medical device industries. They provide support to companies in the form of research services outsourced on a contract basis. In this comprehensive guide, we will explore what CROs are, who their clients are, the stages of the research process they are typically involved in, and delve into the exciting career opportunities within the field of clinical research.

Table of Contents

Introduction to Clinical Research Organizations (CROs)  The Role of CROs in the Research Process  Services Offered by CROs  Clients and Partners of CROs  Careers in Clinical Research  Clinical Research Associate (CRA) Roles and Responsibilities  Educational and Professional Requirements for Clinical Research  Careers Advancement Opportunities in Clinical Research  Tips for Success in Clinical Research  Careers Resources and Professional Organizations  Conclusion

Introduction to Clinical Research Organizations (CROs)

Clinical Research Organizations (CROs) are companies that provide support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. They offer a wide range of services , including biopharmaceutical development, clinical development, clinical trials management, and pharmacovigilance. CROs aim to simplify the entry into drug markets and streamline the drug development process by providing specialized expertise and resources.

The Role of CROs in the Research Process

CROs play a crucial role in the research process, from the early stages of drug discovery and development to the final stages of clinical trials and commercialization. They work closely with their clients to design and execute clinical trials, ensuring adherence to regulatory requirements and ethical standards. CROs also provide support in data management, statistical analysis, and the preparation of regulatory submissions.

Services Offered by CROs

CROs offer a wide range of services to their clients, including but not limited to: 

Biopharmaceutical development : CROs assist in the development of new drugs, from preclinical studies to early-phase clinical trials. Clinical development: CROs design and manage clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Clinical trials management: CROs oversee all aspects of clinical trials, including site selection, patient recruitment, data collection, and safety monitoring. 

Pharmacovigilance : CROs monitor the safety of drugs and medical devices during clinical trials and after they are on the market. 

Real-world evidence and outcomes research : CROs collect and analyze data from real-world sources, such as electronic health records, to generate evidence on the safety and effectiveness of drugs and medical devices. CROs conduct studies to evaluate the effectiveness and safety of drugs and medical devices in real-world settings. 

Clients and Partners of CROs

CROs work with a diverse range of clients, including pharmaceutical  companies,  biotechnology firms, medical device manufacturers, research institutions, and government organizations . They collaborate closely with their clients to ensure that research studies are conducted efficiently, safely, and in compliance with regulatory requirements. CROs also partner with academic institutions and foundations to support their research initiatives.

Careers in Clinical Research

Clinical research offers exciting career opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. 

Careers in clinical research span a wide range of roles, including Clinical Research Associate (CRA), Clinical Project Manager, Data Manager, Biostatistician, and Medical Writer, among others. These roles require a combination of scientific knowledge, attention to detail, critical thinking, and strong communication skills.

Clinical Research Associate (CRA) Roles and Responsibilities

Clinical Research Associates (CRAs) play a crucial role in the execution and monitoring of clinical trials. Their responsibilities include site selection and initiation, monitoring study progress, ensuring compliance with protocols and regulatory requirements, and maintaining accurate and complete documentation. CRAs work closely with investigators, study coordinators, and other stakeholders to ensure that trials are conducted safely and efficiently.

Educational and Professional Requirements for Clinical Research Careers

Careers in clinical research typically require a strong educational background in life sciences or a related field. Many positions, such as CRAs, require a bachelor's or master's degree in a scientific discipline. Professional certifications, such as the Certified Clinical Research Associate (CCRA) certification, can enhance career prospects and demonstrate expertise in the field.

Advancement Opportunities in Clinical Research

Clinical research offers ample opportunities for career advancement and professional growth. Experienced professionals can progress to more senior roles, such as Clinical Project Manager or Clinical Operations Director, where they oversee the planning and execution of multiple clinical trials. Continuing education, networking, and staying updated with industry trends are essential for career advancement in clinical research.

Tips for success in seeking a Career in Clinical Research

To succeed in clinical research careers, professionals should continuously develop their scientific knowledge, stay updated with regulatory requirements, and enhance their communication and project management skills. Networking, building relationships with key stakeholders, and seeking mentorship can also contribute to career advancement in the field.

Resources and Professional Organizations for Clinical Research Professionals

Several resources and professional organizations cater to the needs of clinical research professionals. These include industry publications, online forums, conferences, and professional associations. Organizations such as the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Associates (SoCRA) provide educational resources, networking opportunities, and professional certifications for clinical research professionals.

Clinical Research Organizations (CROs) play a vital role in the pharmaceutical, biotechnology, and medical device industries by providing research services on a contract basis. They offer a wide range of services to support the development and execution of clinical trials, ensuring compliance with regulatory requirements and ethical standards. 

Careers in clinical research offer exciting opportunities for individuals interested in the scientific, regulatory, and operational aspects of drug development. By partnering with CROs and pursuing careers in clinical research, professionals can contribute to the advancement of medical science and the development of innovative therapies.

If you're interested in exploring careers opportunities in clinical research, view our current vacancies at ICON today.

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What is a Contract Research Organization (CRO)?

In a world where medical breakthroughs are becoming increasingly complex, Contract Research Organizations (CROs) are an invaluable resource for pharmaceutical and biotechnology companies. They provide services such as data management, clinical project management, biostatistics, medical writing , and regulatory compliance that enable businesses to develop more effective treatments faster and more efficiently.

By partnering with a CRO, companies can reduce costs while gaining access to specialized expertise—bringing life-saving treatments to the market in record time.

CROs are one of the most important and valuable assets when it comes to medical research organizations. They can provide clinical trial guidance and support for pharmaceutical, and biotechnology companies, and provide helpful resources and knowledge that can be key for your project to run smoothly.

Working with a CRO, businesses can save time and resources while also gaining access to valuable knowledge and technology. Working with the right CRO is key to ensuring success in drug development projects; by selecting a CRO that meets their needs.

Investing in the services of a CRO can be incredibly beneficial for your organization as they specialize in overseeing large portions of clinical trials on behalf of their clients. Read further to learn all about what makes up this type of medical research organization.

Definition of Contract Research Organizations/Clinical Research Organizations

Contract Research Organizations (CROs) and Clinical Research Organizations (CROs) are companies hired by pharmaceutical and biotech corporations or research centers to take over certain parts of running a clinical study and play a crucial role in the world of medical research and clinical trials.

These organizations help manage complex projects that involve testing new drugs, treatments, and medical devices. CROs provide a range of services, from project planning to data collection and analysis, and work alongside pharmaceutical and biotech companies to ensure that clinical trials are conducted safely, efficiently, and in compliance with regulations.

Through their expertise in project management, CROs help to accelerate the development of new treatments and bring them to market faster, ultimately benefiting patients in need.

Purpose and Role of CROs in the Pharmaceutical and Biotechnology Industries

CROs provide essential services to pharmaceutical and biotechnology companies in order to advance their research and drug development efforts.

Pharmaceutical and biotechnology industries rely heavily on clinical development and trials to ensure the safety and effectiveness of their products.

The clinical trial process, however, is not an easy feat. It requires precision, accuracy, and keen attention to detail. This is where contract research organizations come in.

CROs are important in helping these companies conduct clinical trials smoothly and efficiently. They assist in various aspects of the clinical trial process, including clinical monitoring, data management, and regulatory compliance. In doing so, they provide support in running successful clinical studies, accelerating the development of new drugs, and advancing medical research.

History and Evolution of CROs

The emergence of CROs has revolutionized the pharmaceutical and biotechnology industries, providing essential services to support companies in their development of more effective treatments.

In the ever-evolving world of drug development, Contract Research Organizations play an integral role in bringing new therapies to market. But how did CROs come to be?

Their history and evolution can be traced back to the early days of clinical trials, where pharmaceutical companies were responsible for conducting their own research. However, as the drug approval process became more complex and global regulations increased, the need for specialized services grew.

Today, CROs offer a range of expertise and support, from preclinical research to post-marketing studies. By partnering with CROs, pharmaceutical companies can accelerate the drug development timeline, while retaining the highest level of quality and compliance.

Current trends and future prospects

One of the current trends in CROs is the increased focus on global coverage and regulatory compliance. As regulations governing drug development become increasingly complex and varied across different markets, companies must ensure that their research processes meet these high standards.

CROs specialize in providing expertise and support to companies with regard to regulatory compliance, helping them stay ahead of the curve.

The future prospects of Contract Research Organizations (CROs) look incredibly promising. CROs are playing an increasingly important role in the development and production of new drugs and medical treatments. As the pharmaceutical industry continues to grow, so too will the demand for CRO services.

The prevalence of CROs in the pharmaceutical industry is on the rise. As drug development continues to evolve and companies strive for faster, more efficient, and cost-effective methods of research, CROs are becoming an invaluable asset to healthcare providers and researchers alike. In the near future, CROs are expected to continue to provide valuable services.

Services Offered by CROs

CROs, play a pivotal role in the development of new drugs and medical interventions. These organizations offer a wide range of services to pharmaceutical companies and other stakeholders in the healthcare industry. They can help with everything from the development of study protocols to the collection of data and publication. They also assist with statistical analysis and the management of regulatory issues.

By outsourcing these tasks to a CRO, companies can streamline their research efforts and focus their resources on core competencies. With the help of CROs, it’s possible to bring life-changing treatments to market faster and more efficiently than ever before.

Preclinical research

CROs provide a range of services related to preclinical research, including the design of study protocols, regulatory support and consulting, data management and biostatistics, medical writing, and publication support.

Preclinical studies involve the testing of drugs to determine safety and efficacy before progressing to clinical testing. The role of CROs in this is to evaluate and test a drug at the drug discovery stage. You can benefit from their knowledge and expertise in the testing stage before submission to the regulatory authorities.

Clinical trials

Clinical trials are studies of drugs or treatments that involve human participants. They are conducted to evaluate the safety and effectiveness of a drug or treatment in order to determine whether it should be approved by regulatory agencies for use in humans.

Clinical trials typically involve administering the drug or treatment to healthy volunteers or patients with a certain condition and then observing its effects.

CROs play a vital role in running a successful clinical trial. Working with a CRO can help ensure that these clinical trials are conducted according to the highest ethical standards and regulatory requirements, while also providing valuable data for decision-making.

Regulatory support and consulting

CROs provide essential support to pharmaceutical companies and other stakeholders in the healthcare industry when it comes to regulatory compliance and consulting services by providing guidance on how to develop protocols and processes that meet standards.

They also provide critical advice to facilitate product development. They are knowledgeable about the regulations and standards in place for drug development, and they use this expertise to assist companies with navigating the complex and ever-changing landscape of regulatory requirements.

Data management and biostatistics

CROs are experts in collecting, organizing, analyzing, and managing large amounts of data. Data management is a crucial element of any clinical trial, as it ensures that the data collected is valid and accurate data.

They provide specialized expertise and technology to help researchers design studies, analyze data, and develop models to explain observed phenomena and draw meaningful conclusions.

The use of CROs helps researchers better understand complex medical data and make evidence-based decisions

Furthermore, they use sophisticated statistical models to analyze complex medical information objectively. All of these services help pharmaceutical companies develop treatments more quickly and bring them to market faster. Ultimately, partnering with a CRO is essential for ensuring that the development process proceeds efficiently and effectively.

Medical writing and publication support

CROs play an important role in the publication of clinical trial research. In-house experts and medical writing teams at CROs are responsible for preparing documents that effectively and accurately summarize clinical trial results for submission to regulatory authorities and journals.

Alternatively, using automated tools like artificial intelligence (AI) for medical writing is another way to speed up the content creation process. In fact, using AI is one of the ways companies in the medical field can boost productivity .

By working with a CRO, companies can ensure that their clinical trial results are properly represented and presented in a clear, concise manner. These documents must be written in accordance with applicable standards, guidelines, and regulations to ensure accuracy and compliance.

Selecting the Right CRO for Your Project

Choosing the right CRO is crucial for the success of your project. The right CRO can cut down costs and ensure that your project runs smoothly, while the wrong one can cause costly delays and setbacks.

To select the right CRO, you need to consider various factors such as expertise, experience, cost, and communication skills. Look for an organization that has a good track record in your specific field of research, and that can provide you with a tailored approach that meets the needs of your project.

Additionally, if you are looking to work with a CRO that is located in a different country, you should pay attention to their language and cultural barriers, and ensure that your communication channels are effective.

By choosing the right CRO, you can increase your chances of success and ultimately bring your project to fruition.

Benefits of Working with a CRO

Access to specialized expertise and technology.

CROs have access to specialized expertise and technology that enable them to provide comprehensive services to companies. CROs are knowledgeable about the regulatory environment, can assist with data management and biostatistics needs, provide valuable support, and help ensure compliance with applicable standards.

Reduced costs and resources needed for research

When partnering with a CRO, companies gain access to specialist knowledge in order to reduce costs while speeding up development timelines. Ultimately this helps bring treatments to market faster and more efficiently as they already have the necessary resources in place to ensure a sped-up process.

Increased accuracy, validity, and objectivity in data collection and analysis

CROs have access to specialized technology and expertise that enable them to ensure quality control throughout the research process. This allows clinical trial results to be accurate, valid, and objective. They provide specialized experience which enables them to design studies that are comprehensive and compliant with applicable regulations. They also employ rigorous protocols to ensure the accuracy of data collected during clinical trials.

Challenges and Potential Drawbacks of Working with a CRO

Cros are often expensive to work with.

Although CROs can provide vast amounts of expertise, resources, and technology, this comes at a cost. Companies may have to pay for all services rendered upfront, making it difficult to budget for large-scale projects. It is important to take the time to understand the costs associated with working with a CRO and compare those against the benefits of outsourcing certain tasks.

Potential loss of control within the project

When partnering with a CRO there is a risk that it could lead to a loss of control over certain aspects of the project It is important for companies to ensure clear communication channels are established so that expectations are managed and all stakeholders remain informed.

Working with a contract research organization (CRO) can provide numerous benefits for businesses in need of research services. By outsourcing research tasks to a CRO, businesses can save time, money, and resources while also gaining access to specialized expertise and technology.

CROs can help design and execute studies, collect and analyze data, and provide valuable insights and recommendations. Additionally, working with a CRO can help businesses maintain objectivity and impartiality in their research while avoiding conflicts of interest.

These research organizations provide specialized expertise that enables them to design studies that comply with regulations, manage data, analyze complex medical information objectively, prepare documents for publication, and ensure compliance with applicable standards.

By working with a CRO, companies can reduce costs while speeding up development timelines which ultimately helps bring treatments to market faster and more efficiently. However, it is important for companies to establish clear communication channels so expectations remain managed throughout the project lifecycle.

Overall, partnering with a CRO is a smart choice for businesses looking to optimize their research efforts and maximize their return on investment.

Austin is a blogger, entrepreneur, and freelance medical writer. He spent 8 years in the pharmacy profession prior to going full-time with his business, Ulrich Medical Writing, LLC. As a blogger, he's passionate about helping others create freedom and time in their lives by earning and keeping more income. He enjoys running, music, and traveling with his wife and 4 kids.

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Clinical Trials and Clinical Research: A Comprehensive Review

Venkataramana kandi.

1 Clinical Microbiology, Prathima Institute of Medical Sciences, Karimnagar, IND

Sabitha Vadakedath

2 Biochemistry, Prathima Institute of Medical Sciences, Karimnagar, IND

Clinical research is an alternative terminology used to describe medical research. Clinical research involves people, and it is generally carried out to evaluate the efficacy of a therapeutic drug, a medical/surgical procedure, or a device as a part of treatment and patient management. Moreover, any research that evaluates the aspects of a disease like the symptoms, risk factors, and pathophysiology, among others may be termed clinical research. However, clinical trials are those studies that assess the potential of a therapeutic drug/device in the management, control, and prevention of disease. In view of the increasing incidences of both communicable and non-communicable diseases, and especially after the effects that Coronavirus Disease-19 (COVID-19) had on public health worldwide, the emphasis on clinical research assumes extremely essential. The knowledge of clinical research will facilitate the discovery of drugs, devices, and vaccines, thereby improving preparedness during public health emergencies. Therefore, in this review, we comprehensively describe the critical elements of clinical research that include clinical trial phases, types, and designs of clinical trials, operations of trial, audit, and management, and ethical concerns.

Introduction and background

A clinical trial is a systematic process that is intended to find out the safety and efficacy of a drug/device in treating/preventing/diagnosing a disease or a medical condition [ 1 , 2 ]. Clinical trial includes various phases that include phase 0 (micro-dosing studies), phase 1, phase 2, phase 3, and phase 4 [ 3 ]. Phase 0 and phase 2 are called exploratory trial phases, phase 1 is termed the non-therapeutic phase, phase 3 is known as the therapeutic confirmatory phase, and phase 4 is called the post-approval or the post-marketing surveillance phase. Phase 0, also called the micro-dosing phase, was previously done in animals but now it is carried out in human volunteers to understand the dose tolerability (pharmacokinetics) before being administered as a part of the phase 1 trial among healthy individuals. The details of the clinical trial phases are shown in Table ​ Table1 1 .

This table has been created by the authors.

MTD: maximum tolerated dose; SAD: single ascending dose; MAD: multiple ascending doses; NDA: new drug application; FDA: food and drug administration

Clinical research design has two major types that include non-interventional/observational and interventional/experimental studies. The non-interventional studies may have a comparator group (analytical studies like case-control and cohort studies), or without it (descriptive study). The experimental studies may be either randomized or non-randomized. Clinical trial designs are of several types that include parallel design, crossover design, factorial design, randomized withdrawal approach, adaptive design, superiority design, and non-inferiority design. The advantages and disadvantages of clinical trial designs are depicted in Table ​ Table2 2 .

There are different types of clinical trials that include those which are conducted for treatment, prevention, early detection/screening, and diagnosis. These studies address the activities of an investigational drug on a disease and its outcomes [ 4 ]. They assess whether the drug is able to prevent the disease/condition, the ability of a device to detect/screen the disease, and the efficacy of a medical test to diagnose the disease/condition. The pictorial representation of a disease diagnosis, treatment, and prevention is depicted in Figure ​ Figure1 1 .

This figure has been created by the authors.

The clinical trial designs could be improvised to make sure that the study's validity is maintained/retained. The adaptive designs facilitate researchers to improvise during the clinical trial without interfering with the integrity and validity of the results. Moreover, it allows flexibility during the conduction of trials and the collection of data. Despite these advantages, adaptive designs have not been universally accepted among clinical researchers. This could be attributed to the low familiarity of such designs in the research community. The adaptive designs have been applied during various phases of clinical trials and for different clinical conditions [ 5 , 6 ]. The adaptive designs applied during different phases are depicted in Figure ​ Figure2 2 .

The Bayesian adaptive trial design has gained popularity, especially during the Coronavirus Disease-19 (COVID-19) pandemic. Such designs could operate under a single master protocol. It operates as a platform trial wherein multiple treatments can be tested on different patient groups suffering from disease [ 7 ].

In this review, we comprehensively discuss the essential elements of clinical research that include the principles of clinical research, planning clinical trials, practical aspects of clinical trial operations, essentials of clinical trial applications, monitoring, and audit, clinical trial data analysis, regulatory audits, and project management, clinical trial operations at the investigation site, the essentials of clinical trial experiments involving epidemiological, and genetic studies, and ethical considerations in clinical research/trials.

A clinical trial involves the study of the effect of an investigational drug/any other intervention in a defined population/participant. The clinical research includes a treatment group and a placebo wherein each group is evaluated for the efficacy of the intervention (improved/not improved) [ 8 ].

Clinical trials are broadly classified into controlled and uncontrolled trials. The uncontrolled trials are potentially biased, and the results of such research are not considered as equally as the controlled studies. Randomized controlled trials (RCTs) are considered the most effective clinical trials wherein the bias is minimized, and the results are considered reliable. There are different types of randomizations and each one has clearly defined functions as elaborated in Table ​ Table3 3 .

Principles of clinical trial/research

Clinical trials or clinical research are conducted to improve the understanding of the unknown, test a hypothesis, and perform public health-related research [ 2 , 3 ]. This is majorly carried out by collecting the data and analyzing it to derive conclusions. There are various types of clinical trials that are majorly grouped as analytical, observational, and experimental research. Clinical research can also be classified into non-directed data capture, directed data capture, and drug trials. Clinical research could be prospective or retrospective. It may also be a case-control study or a cohort study. Clinical trials may be initiated to find treatment, prevent, observe, and diagnose a disease or a medical condition.

Among the various types of clinical research, observational research using a cross-sectional study design is the most frequently performed clinical research. This type of research is undertaken to analyze the presence or absence of a disease/condition, potential risk factors, and prevalence and incidence rates in a defined population. Clinical trials may be therapeutic or non-therapeutic type depending on the type of intervention. The therapeutic type of clinical trial uses a drug that may be beneficial to the patient. Whereas in a non-therapeutic clinical trial, the participant does not benefit from the drug. The non-therapeutic trials provide additional knowledge of the drug for future improvements. Different terminologies of clinical trials are delineated in Table ​ Table4 4 .

In view of the increased cost of the drug discovery process, developing, and low-income countries depend on the production of generic drugs. The generic drugs are similar in composition to the patented/branded drug. Once the patent period is expired generic drugs can be manufactured which have a similar quality, strength, and safety as the patented drug [ 9 ]. The regulatory requirements and the drug production process are almost the same for the branded and the generic drug according to the Food and Drug Administration (FDA), United States of America (USA).

The bioequivalence (BE) studies review the absorption, distribution, metabolism, and excretion (ADME) of the generic drug. These studies compare the concentration of the drug at the desired location in the human body, called the peak concentration of the drug (Cmax). The extent of absorption of the drug is measured using the area under the receiver operating characteristic curve (AUC), wherein the generic drug is supposed to demonstrate similar ADME activities as the branded drug. The BE studies may be undertaken in vitro (fasting, non-fasting, sprinkled fasting) or in vivo studies (clinical, bioanalytical, and statistical) [ 9 ].

Planning clinical trial/research

The clinical trial process involves protocol development, designing a case record/report form (CRF), and functioning of institutional review boards (IRBs). It also includes data management and the monitoring of clinical trial site activities. The CRF is the most significant document in a clinical study. It contains the information collected by the investigator about each subject participating in a clinical study/trial. According to the International Council for Harmonisation (ICH), the CRF can be printed, optical, or an electronic document that is used to record the safety and efficacy of the pharmaceutical drug/product in the test subjects. This information is intended for the sponsor who initiates the clinical study [ 10 ].

The CRF is designed as per the protocol and later it is thoroughly reviewed for its correctness (appropriate and structured questions) and finalized. The CRF then proceeds toward the print taking the language of the participating subjects into consideration. Once the CRF is printed, it is distributed to the investigation sites where it is filled with the details of the participating subjects by the investigator/nurse/subject/guardian of the subject/technician/consultant/monitors/pharmacist/pharmacokinetics/contract house staff. The filled CRFs are checked for their completeness and transported to the sponsor [ 11 ].

Effective planning and implementation of a clinical study/trial will influence its success. The clinical study majorly includes the collection and distribution of the trial data, which is done by the clinical data management section. The project manager is crucial to effectively plan, organize, and use the best processes to control and monitor the clinical study [ 10 , 11 ].

The clinical study is conducted by a sponsor or a clinical research organization (CRO). A perfect protocol, time limits, and regulatory requirements assume significance while planning a clinical trial. What, when, how, and who are clearly planned before the initiation of a study trial. Regular review of the project using the bar and Gantt charts, and maintaining the timelines assume increased significance for success with the product (study report, statistical report, database) [ 10 , 11 ].

The steps critical to planning a clinical trial include the idea, review of the available literature, identifying a problem, formulating the hypothesis, writing a synopsis, identifying the investigators, writing a protocol, finding a source of funding, designing a patient consent form, forming ethics boards, identifying an organization, preparing manuals for procedures, quality assurance, investigator training and initiation of the trial by recruiting the participants [ 10 ].

The two most important points to consider before the initiation of the clinical trial include whether there is a need for a clinical trial, if there is a need, then one must make sure that the study design and methodology are strong for the results to be reliable to the people [ 11 ].

For clinical research to envisage high-quality results, the study design, implementation of the study, quality assurance in data collection, and alleviation of bias and confounding factors must be robust [ 12 ]. Another important aspect of conducting a clinical trial is improved management of various elements of clinical research that include human and financial resources. The role of a trial manager to make a successful clinical trial was previously reported. The trial manager could play a key role in planning, coordinating, and successfully executing the trial. Some qualities of a trial manager include better communication and motivation, leadership, and strategic, tactical, and operational skills [ 13 ].

Practical aspects of a clinical trial operations

There are different types of clinical research. Research in the development of a novel drug could be initiated by nationally funded research, industry-sponsored research, and clinical research initiated by individuals/investigators. According to the documents 21 code of federal regulations (CFR) 312.3 and ICH E-6 Good Clinical Practice (GCP) 1.54, an investigator is an individual who initiates and conducts clinical research [ 14 ]. The investigator plan, design, conduct, monitor, manage data, compile reports, and supervise research-related regulatory and ethical issues. To manage a successful clinical trial project, it is essential for an investigator to give the letter of intent, write a proposal, set a timeline, develop a protocol and related documents like the case record forms, define the budget, and identify the funding sources.

Other major steps of clinical research include the approval of IRBs, conduction and supervision of the research, data review, and analysis. Successful clinical research includes various essential elements like a letter of intent which is the evidence that supports the interest of the researcher to conduct drug research, timeline, funding source, supplier, and participant characters.

Quality assurance, according to the ICH and GCP guidelines, is necessary to be implemented during clinical research to generate quality and accurate data. Each element of the clinical research must have been carried out according to the standard operating procedure (SOP), which is written/determined before the initiation of the study and during the preparation of the protocol [ 15 ].

The audit team (quality assurance group) is instrumental in determining the authenticity of the clinical research. The audit, according to the ICH and GCP, is an independent and external team that examines the process (recording the CRF, analysis of data, and interpretation of data) of clinical research. The quality assurance personnel are adequately trained, become trainers if needed, should be good communicators, and must handle any kind of situation. The audits can be at the investigator sites evaluating the CRF data, the protocol, and the personnel involved in clinical research (source data verification, monitors) [ 16 ].

Clinical trial operations are governed by legal and regulatory requirements, based on GCPs, and the application of science, technology, and interpersonal skills [ 17 ]. Clinical trial operations are complex, time and resource-specific that requires extensive planning and coordination, especially for the research which is conducted at multiple trial centers [ 18 ].

Recruiting the clinical trial participants/subjects is the most significant aspect of clinical trial operations. Previous research had noted that most clinical trials do not meet the participant numbers as decided in the protocol. Therefore, it is important to identify the potential barriers to patient recruitment [ 19 ].

Most clinical trials demand huge costs, increased timelines, and resources. Randomized clinical trial studies from Switzerland were analyzed for their costs which revealed approximately 72000 USD for a clinical trial to be completed. This study emphasized the need for increased transparency with respect to the costs associated with the clinical trial and improved collaboration between collaborators and stakeholders [ 20 ].

Clinical trial applications, monitoring, and audit

Among the most significant aspects of a clinical trial is the audit. An audit is a systematic process of evaluating the clinical trial operations at the site. The audit ensures that the clinical trial process is conducted according to the protocol, and predefined quality system procedures, following GCP guidelines, and according to the requirements of regulatory authorities [ 21 ].

The auditors are supposed to be independent and work without the involvement of the sponsors, CROs, or personnel at the trial site. The auditors ensure that the trial is conducted by designated professionally qualified, adequately trained personnel, with predefined responsibilities. The auditors also ensure the validity of the investigational drug, and the composition, and functioning of institutional review/ethics committees. The availability and correctness of the documents like the investigational broacher, informed consent forms, CRFs, approval letters of the regulatory authorities, and accreditation of the trial labs/sites [ 21 ].

The data management systems, the data collection software, data backup, recovery, and contingency plans, alternative data recording methods, security of the data, personnel training in data entry, and the statistical methods used to analyze the results of the trial are other important responsibilities of the auditor [ 21 , 22 ].

According to the ICH-GCP Sec 1.29 guidelines the inspection may be described as an act by the regulatory authorities to conduct an official review of the clinical trial-related documents, personnel (sponsor, investigator), and the trial site [ 21 , 22 ]. The summary report of the observations of the inspectors is performed using various forms as listed in Table ​ Table5 5 .

FDA: Food and Drug Administration; IND: investigational new drug; NDA: new drug application; IRB: institutional review board; CFR: code of federal regulations

Because protecting data integrity, the rights, safety, and well-being of the study participants are more significant while conducting a clinical trial, regular monitoring and audit of the process appear crucial. Also, the quality of the clinical trial greatly depends on the approach of the trial personnel which includes the sponsors and investigators [ 21 ].

The responsibility of monitoring lies in different hands, and it depends on the clinical trial site. When the trial is initiated by a pharmaceutical industry, the responsibility of trial monitoring depends on the company or the sponsor, and when the trial is conducted by an academic organization, the responsibility lies with the principal investigator [ 21 ].

An audit is a process conducted by an independent body to ensure the quality of the study. Basically, an audit is a quality assurance process that determines if a study is carried out by following the SPOs, in compliance with the GCPs recommended by regulatory bodies like the ICH, FDA, and other local bodies [ 21 ].

An audit is performed to review all the available documents related to the IRB approval, investigational drug, and the documents related to the patient care/case record forms. Other documents that are audited include the protocol (date, sign, treatment, compliance), informed consent form, treatment response/outcome, toxic response/adverse event recording, and the accuracy of data entry [ 22 ].

Clinical trial data analysis, regulatory audits, and project management

The essential elements of clinical trial management systems (CDMS) include the management of the study, the site, staff, subject, contracts, data, and document management, patient diary integration, medical coding, monitoring, adverse event reporting, supplier management, lab data, external interfaces, and randomization. The CDMS involves setting a defined start and finishing time, defining study objectives, setting enrolment and termination criteria, commenting, and managing the study design [ 23 ].

Among the various key application areas of clinical trial systems, the data analysis assumes increased significance. The clinical trial data collected at the site in the form of case record form is stored in the CDMS ensuring the errors with respect to the double data entry are minimized.

Clinical trial data management uses medical coding, which uses terminologies with respect to the medications and adverse events/serious adverse events that need to be entered into the CDMS. The project undertaken to conduct the clinical trial must be predetermined with timelines and milestones. Timelines are usually set for the preparation of protocol, designing the CRF, planning the project, identifying the first subject, and timelines for recording the patient’s data for the first visit.

The timelines also are set for the last subject to be recruited in the study, the CRF of the last subject, and the locked period after the last subject entry. The planning of the project also includes the modes of collection of the data, the methods of the transport of the CRFs, patient diaries, and records of severe adverse events, to the central data management sites (fax, scan, courier, etc.) [ 24 ].

The preparation of SOPs and the type and timing of the quality control (QC) procedures are also included in the project planning before the start of a clinical study. Review (budget, resources, quality of process, assessment), measure (turnaround times, training issues), and control (CRF collection and delivery, incentives, revising the process) are the three important aspects of the implementation of a clinical research project.

In view of the increasing complexity related to the conduct of clinical trials, it is important to perform a clinical quality assurance (CQA) audit. The CQA audit process consists of a detailed plan for conducting audits, points of improvement, generating meaningful audit results, verifying SOP, and regulatory compliance, and promoting improvement in clinical trial research [ 25 ]. All the components of a CQA audit are delineated in Table ​ Table6 6 .

CRF: case report form; CSR: clinical study report; IC: informed consent; PV: pharmacovigilance; SAE: serious adverse event

Clinical trial operations at the investigator's site

The selection of an investigation site is important before starting a clinical trial. It is essential that the individuals recruited for the study meet the inclusion criteria of the trial, and the investigator's and patient's willingness to accept the protocol design and the timelines set by the regulatory authorities including the IRBs.

Before conducting clinical research, it is important for an investigator to agree to the terms and conditions of the agreement and maintain the confidentiality of the protocol. Evaluation of the protocol for the feasibility of its practices with respect to the resources, infrastructure, qualified and trained personnel available, availability of the study subjects, and benefit to the institution and the investigator is done by the sponsor during the site selection visit.

The standards of a clinical research trial are ensured by the Council for International Organizations of Medical Sciences (CIOMS), National Bioethics Advisory Commission (NBAC), United Nations Programme on Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS) (UNAIDS), and World Medical Association (WMA) [ 26 ].

Recommendations for conducting clinical research based on the WMA support the slogan that says, “The health of my patient will be my first consideration.” According to the International Code of Medical Ethics (ICME), no human should be physically or mentally harmed during the clinical trial, and the study should be conducted in the best interest of the person [ 26 ].

Basic principles recommended by the Helsinki declaration include the conduction of clinical research only after the prior proof of the safety of the drug in animal and lab experiments. The clinical trials must be performed by scientifically, and medically qualified and well-trained personnel. Also, it is important to analyze the benefit of research over harm to the participants before initiating the drug trials.

The doctors may prescribe a drug to alleviate the suffering of the patient, save the patient from death, and gain additional knowledge of the drug only after obtaining informed consent. Under the equipoise principle, the investigators must be able to justify the treatment provided as a part of the clinical trial, wherein the patient in the placebo arm may be harmed due to the unavailability of the therapeutic/trial drug.

Clinical trial operations greatly depend on the environmental conditions and geographical attributes of the trial site. It may influence the costs and targets defined by the project before the initiation. It was noted that one-fourth of the clinical trial project proposals/applications submit critical data on the investigational drug from outside the country. Also, it was noted that almost 35% of delays in clinical trials owing to patient recruitment with one-third of studies enrolling only 5% of the participants [ 27 ].

It was suggested that clinical trial feasibility assessment in a defined geographical region may be undertaken for improved chances of success. Points to be considered under the feasibility assessment program include if the disease under the study is related to the population of the geographical region, appropriateness of the study design, patient, and comparator group, visit intervals, potential regulatory and ethical challenges, and commitments of the study partners, CROs in respective countries (multi-centric studies) [ 27 ].

Feasibility assessments may be undertaken at the program level (ethics, regulatory, and medical preparedness), study level (clinical, regulatory, technical, and operational aspects), and at the investigation site (investigational drug, competency of personnel, participant recruitment, and retention, quality systems, and infrastructural aspects) [ 27 ].

Clinical trials: true experiments

In accordance with the revised schedule "Y" of the Drugs and Cosmetics Act (DCA) (2005), a drug trial may be defined as a systematic study of a novel drug component. The clinical trials aim to evaluate the pharmacodynamic, and pharmacokinetic properties including ADME, efficacy, and safety of new drugs.

According to the drug and cosmetic rules (DCR), 1945, a new chemical entity (NCE) may be defined as a novel drug approved for a disease/condition, in a specified route, and at a particular dosage. It also may be a new drug combination, of previously approved drugs.

A clinical trial may be performed in three types; one that is done to find the efficacy of an NCE, a comparison study of two drugs against a medical condition, and the clinical research of approved drugs on a disease/condition. Also, studies of the bioavailability and BE studies of the generic drugs, and the drugs already approved in other countries are done to establish the efficacy of new drugs [ 28 ].

Apart from the discovery of a novel drug, clinical trials are also conducted to approve novel medical devices for public use. A medical device is defined as any instrument, apparatus, appliance, software, and any other material used for diagnostic/therapeutic purposes. The medical devices may be divided into three classes wherein class I uses general controls; class II uses general and special controls, and class III uses general, special controls, and premarket approvals [ 28 ].

The premarket approval applications ensure the safety and effectiveness, and confirmation of the activities from bench to animal to human clinical studies. The FDA approval for investigational device exemption (IDE) for a device not approved for a new indication/disease/condition. There are two types of IDE studies that include the feasibility study (basic safety and potential effectiveness) and the pivotal study (trial endpoints, randomization, monitoring, and statistical analysis plan) [ 28 ].

As evidenced by the available literature, there are two types of research that include observational and experimental research. Experimental research is alternatively known as the true type of research wherein the research is conducted by the intervention of a new drug/device/method (educational research). Most true experiments use randomized control trials that remove bias and neutralize the confounding variables that may interfere with the results of research [ 28 ].

The variables that may interfere with the study results are independent variables also called prediction variables (the intervention), dependent variables (the outcome), and extraneous variables (other confounding factors that could influence the outside). True experiments have three basic elements that include manipulation (that influence independent variables), control (over extraneous influencers), and randomization (unbiased grouping) [ 29 ].

Experiments can also be grouped as true, quasi-experimental, and non-experimental studies depending on the presence of specific characteristic features. True experiments have all three elements of study design (manipulation, control, randomization), and prospective, and have great scientific validity. Quasi-experiments generally have two elements of design (manipulation and control), are prospective, and have moderate scientific validity. The non-experimental studies lack manipulation, control, and randomization, are generally retrospective, and have low scientific validity [ 29 ].

Clinical trials: epidemiological and human genetics study

Epidemiological studies are intended to control health issues by understanding the distribution, determinants, incidence, prevalence, and impact on health among a defined population. Such studies are attempted to perceive the status of infectious diseases as well as non-communicable diseases [ 30 ].

Experimental studies are of two types that include observational (cross-sectional studies (surveys), case-control studies, and cohort studies) and experimental studies (randomized control studies) [ 3 , 31 ]. Such research may pose challenges related to ethics in relation to the social and cultural milieu.

Biomedical research related to human genetics and transplantation research poses an increased threat to ethical concerns, especially after the success of the human genome project (HGP) in the year 2000. The benefits of human genetic studies are innumerable that include the identification of genetic diseases, in vitro fertilization, and regeneration therapy. Research related to human genetics poses ethical, legal, and social issues (ELSI) that need to be appropriately addressed. Most importantly, these genetic research studies use advanced technologies which should be equally available to both economically well-placed and financially deprived people [ 32 ].

Gene therapy and genetic manipulations may potentially precipitate conflict of interest among the family members. The research on genetics may be of various types that include pedigree studies (identifying abnormal gene carriers), genetic screening (for diseases that may be heritable by the children), gene therapeutics (gene replacement therapy, gene construct administration), HGP (sequencing the whole human genome/deoxyribonucleic acid (DNA) fingerprinting), and DNA, cell-line banking/repository [ 33 ]. The biobanks are established to collect and store human tissue samples like umbilical tissue, cord blood, and others [ 34 ].

Epidemiological studies on genetics are attempts to understand the prevalence of diseases that may be transmitted among families. The classical epidemiological studies may include single case observations (one individual), case series (< 10 individuals), ecological studies (population/large group of people), cross-sectional studies (defined number of individuals), case-control studies (defined number of individuals), cohort (defined number of individuals), and interventional studies (defined number of individuals) [ 35 ].

Genetic studies are of different types that include familial aggregation (case-parent, case-parent-grandparent), heritability (study of twins), segregation (pedigree study), linkage study (case-control), association, linkage, disequilibrium, cohort case-only studies (related case-control, unrelated case-control, exposure, non-exposure group, case group), cross-sectional studies, association cohort (related case-control, familial cohort), and experimental retrospective cohort (clinical trial, exposure, and non-exposure group) [ 35 ].

Ethics and concerns in clinical trial/research

Because clinical research involves animals and human participants, adhering to ethics and ethical practices assumes increased significance [ 36 ]. In view of the unethical research conducted on war soldiers after the Second World War, the Nuremberg code was introduced in 1947, which promulgated rules for permissible medical experiments on humans. The Nuremberg code suggests that informed consent is mandatory for all the participants in a clinical trial, and the study subjects must be made aware of the nature, duration, and purpose of the study, and potential health hazards (foreseen and unforeseen). The study subjects should have the liberty to withdraw at any time during the trial and to choose a physician upon medical emergency. The other essential principles of clinical research involving human subjects as suggested by the Nuremberg code included benefit to the society, justification of study as noted by the results of the drug experiments on animals, avoiding even minimal suffering to the study participants, and making sure that the participants don’t have life risk, humanity first, improved medical facilities for participants, and suitably qualified investigators [ 37 ].

During the 18th world medical assembly meeting in the year 1964, in Helsinki, Finland, ethical principles for doctors practicing research were proposed. Declaration of Helsinki, as it is known made sure that the interests and concerns of the human participants will always prevail over the interests of the society. Later in 1974, the National Research Act was proposed which made sure that the research proposals are thoroughly screened by the Institutional ethics/Review Board. In 1979, the April 18th Belmont report was proposed by the national commission for the protection of human rights during biomedical and behavioral research. The Belmont report proposed three core principles during research involving human participants that include respect for persons, beneficence, and justice. The ICH laid down GCP guidelines [ 38 ]. These guidelines are universally followed throughout the world during the conduction of clinical research involving human participants.

ICH was first founded in 1991, in Brussels, under the umbrella of the USA, Japan, and European countries. The ICH conference is conducted once every two years with the participation from the member countries, observers from the regulatory agencies, like the World Health Organization (WHO), European Free Trade Association (EFTA), and the Canadian Health Protection Branch, and other interested stakeholders from the academia and the industry. The expert working groups of the ICH ensure the quality, efficacy, and safety of the medicinal product (drug/device). Despite the availability of the Nuremberg code, the Belmont Report, and the ICH-GCP guidelines, in the year 1982, International Ethical Guidelines for Biomedical Research Involving Human Subjects was proposed by the CIOMS in association with WHO [ 39 ]. The CIOMS protects the rights of the vulnerable population, and ensures ethical practices during clinical research, especially in underdeveloped countries [ 40 ]. In India, the ethical principles for biomedical research involving human subjects were introduced by the Indian Council of Medical Research (ICMR) in the year 2000 and were later amended in the year 2006 [ 41 ]. Clinical trial approvals can only be done by the IRB approved by the Drug Controller General of India (DGCI) as proposed in the year 2013 [ 42 ].

Current perspectives and future implications

A recent study attempted to evaluate the efficacy of adaptive clinical trials in predicting the success of a clinical trial drug that entered phase 3 and minimizing the time and cost of drug development. This study highlighted the drawbacks of such clinical trial designs that include the possibility of type 1 (false positive) and type 2 (false negative) errors [ 43 ].

The usefulness of animal studies during the preclinical phases of a clinical trial was evaluated in a previous study which concluded that animal studies may not completely guarantee the safety of the investigational drug. This is noted by the fact that many drugs which passed toxicity tests in animals produced adverse reactions in humans [ 44 ].

The significance of BE studies to compare branded and generic drugs was reported previously. The pharmacokinetic BE studies of Amoxycillin comparing branded and generic drugs were carried out among a group of healthy participants. The study results have demonstrated that the generic drug had lower Cmax as compared to the branded drug [ 45 ].

To establish the BE of the generic drugs, randomized crossover trials are carried out to assess the Cmax and the AUC. The ratio of each pharmacokinetic characteristic must match the ratio of AUC and/or Cmax, 1:1=1 for a generic drug to be considered as a bioequivalent to a branded drug [ 46 ].

Although the generic drug development is comparatively more beneficial than the branded drugs, synthesis of extended-release formulations of the generic drug appears to be complex. Since the extended-release formulations remain for longer periods in the stomach, they may be influenced by gastric acidity and interact with the food. A recent study suggested the use of bio-relevant dissolution tests to increase the successful production of generic extended-release drug formulations [ 47 ].

Although RCTs are considered the best designs, which rule out bias and the data/results obtained from such clinical research are the most reliable, RCTs may be plagued by miscalculation of the treatment outcomes/bias, problems of cointerventions, and contaminations [ 48 ].

The perception of healthcare providers regarding branded drugs and their view about the generic equivalents was recently analyzed and reported. It was noted that such a perception may be attributed to the flexible regulatory requirements for the approval of a generic drug as compared to a branded drug. Also, could be because a switch from a branded drug to a generic drug in patients may precipitate adverse events as evidenced by previous reports [ 49 ].

Because the vulnerable population like drug/alcohol addicts, mentally challenged people, children, geriatric age people, military persons, ethnic minorities, people suffering from incurable diseases, students, employees, and pregnant women cannot make decisions with respect to participating in a clinical trial, ethical concerns, and legal issues may prop up, that may be appropriately addressed before drug trials which include such groups [ 50 ].

Conclusions

Clinical research and clinical trials are important from the public health perspective. Clinical research facilitates scientists, public health administrations, and people to increase their understanding and improve preparedness with reference to the diseases prevalent in different geographical regions of the world. Moreover, clinical research helps in mitigating health-related problems as evidenced by the current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) pandemic and other emerging and re-emerging microbial infections. Clinical trials are crucial to the development of drugs, devices, and vaccines. Therefore, scientists are required to be up to date with the process and procedures of clinical research and trials as discussed comprehensively in this review.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Chapter 3. The Role of Academic Research Organizations in Clinical Research

Craig J. Reist; Tyrus L. Rorick; Lisa G. Berdan; Renato D. Lopes

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• Introduction
• The Early Years
• ARO Values and Principles
• Comparing and Contrasting CROs and AROs
• ARO Commitment to Education and Training
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• Supplementary Content

The label academic research organization (ARO), used broadly within the clinical and drug development industries, primarily refers to an academic and/or nonprofit institution that performs one or more functions in the conduct of clinical trials. The services that an ARO provides can range from academic leadership to full-service clinical trial management capabilities, including site monitoring, data management, statistical analysis, safety monitoring, and clinical events classification, in addition to clinical expertise.

The concept of an ARO dates back several decades, when researchers recognized the need for large global clinical trials to answer important medical questions. Clinical scientists from several of the world's leading academic institutions formed teams of like-minded investigators with the goal of developing and conducting global clinical studies to improve patient care. AROs are focused on developing and sharing knowledge with the end goal of improving patient care. They accomplish this goal not only by leading and conducting multinational clinical trials but also by ensuring that the results from these trials are published and presented. These groups also focus on managing major national patient registries designed to collect data and determine best practices, which can then be incorporated into clinical practice guidelines. Education and development of clinical investigators is also a focus, with many of the leading AROs having fellowship programs whose influence extends around the globe.

The concept of the ARO dates back to the late 1980s, when several groups of physician investigators first came together to address unmet clinical needs by organizing and centralizing the operational efforts associated with conducting large multicenter clinical trials, so-called “megatrials.” The first such group, located at the University of Oxford in the United Kingdom, developed in 1975 from a single research team. It began enrollment of the then-largest trial in history—6,027 patients with suspected acute myocardial infarction (MI)—in mid-1981, completed enrollment at the 245 participating coronary care units in 1985, and published the results the next year ( 1 ). Similarly, the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico (GISSI), formed from a collaboration between the Mario Negri Institute and the Associazione Nazionale dei Medici Cardiologi Ospedalieri, began enrolling 11,806 patients with acute MI in 176 Italian intensive care units in 1984. It published the study results 2 years later ( 2 ). Both groups have since continued to perform large, important multicenter trials.

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Top 17 Clinical Research Organizations (CRO) in 2023

In clinical research and treatment development, clinical research organizations (CROs) are frequently a sponsor’s most important partner and ally.

Depending on the nature of the clinical trial, and your existing capabilities as a sponsor to run the trial, the CRO company of your choice will typically be responsible for facilitating most of the micro and macro processes that go into designing and running a successful clinical trial.

When contracting a CRO to help you with your trial, you are transferring over a large portion of responsibility into the hands of your clinical research partner. The CRO of your choice will have the responsibility to control a variety of factors and processes of a clinical trial, and depending on their expertise, team structures, service offerings, internal resources and many other capabilities.

Your ability to find and contract a top CRO company that is the right fit for your unique trial will be a determinant of whether or not you will be able to operate a high-quality clinical trial that meets your expected timelines, budget and delivers a top-notch patient experience.

At ClaraHealth (a patient-centric recruitment acceleration platform) , we have put together an extensive list of the top CRO companies in the US and around the world.

This is not a cro rankings list, but rather a compiled list of some of the top clinical research organizations around the world. We have highlighted their strengths and core service offerings to make it easier for you to find the right fit clinical research partner.

In addition, we’ve put together a list of 9 fundamental questions to ask the prospective clinical research organization , which will help you to save time and ensure a right fit in picking the CRO.

Formerly known as Quintiles and IMS Health, IQVIA is one of the largest CROs in the world, with a large range of service offerings to help advance clinical research.

The company was founded in North Carolina in 1982, and has since grown to over 88,000 employees in more than 100 countries.

Some clinical trial solutions offered by IQVIA include:

• Assistance with protocol design
• Design of phase 1 clinical trials
• Assessment and improvement of phase 2 and 3 clinical trials
• Site identification & selection
• Patient recruitment
• Access to global laboratories via their wholly owned subsidiary Q2 Solutions

Parexel is a global clinical research organization that was founded in 1982, and specializes in conducting clinical studies on behalf of its pharmaceutical partners in order to accelerate and ensure the drug approval process of up-and-coming potential treatments. It currently operates in more than 50 countries, and is run by more than 18,000 employees around the world.

The company has a wide range of service offerings, covering nearly every type of clinical trial service to assist sponsors in running successful clinical studies.

Some clinical trial solutions offered by Parexel include:

• Clinical trial design and development for early phase, phase 2 & 3, and late phase clinical trials
• Clinical data management
• Decentralized clinical trials
• Clinical supply chain management
• Medical writing
• Regulatory affairs consulting
• Pharmacovigilance

3. PRA Health Sciences

PRA Health Sciences is one of the largest contract research organizations in the world. Founded in 1976 under the name “Anti-Inflammatory Drug Study Group”, the company was renamed to PRA in 1982. PRA Health Sciences employees more than 17,000 people, and provides coverage to more than 90 countries.

In 2021, PRA Health Sciences was acquired by the Ireland-headquartered global CRO leader ICON, which is also reviewed in this list.

Some clinical trial solutions offered by PRA Health Sciences include:

• Decentralized Clinical Trials Platform
• Protocol Consultation & Study Design
• Onsite Support services
• Customized Solutions for Biotech (such as asset valuation, regulatory strategy, engagement and support, drug development strategy and funding solutions)
• Clinical Diagnostics
• Site Commercial Solutions
• PRA’s Laboratories for Drug Development

Headquartered in Ireland, ICON was founded in 1990 in Dublin by co-founders John Climax and Ronan Lambre. The company has since grown to be one of the largest CROs in the world. As of September 2020, the company employs more than 15,000 people in 94 locations and across 40 countries.

ICON offers clinical research services which include consulting, clinical development and commercialization across a wide range of therapeutic areas.

In 2021, ICON acquired PRA Health Sciences, which is another CRO and global leader in clinical research services.

Some clinical trial solutions offered by ICON:

• Commercial Positioning
• Early Phase
• Functional Services Provision
• Laboratories
• Language Services
• Medical Imaging
• Real World Intelligence
• Site & Patient Solutions
• COVID-19 Clinical Operations

5. Syneos Health

Formerly known as InVentiv Health Incorporated and INC Research, Syneos Health is a publicly listed and global contract research organization. The company is based in Morrisville, North Carolina, and specializes in assisting companies with late-stage clinical trials. Syneos Health currently employs more than 25,000 people, and has offices across 91 locations.

In early 2018, INC Research was acquired inVentiv Health, and the merged company was named Syneos Health.

Some clinical trial solutions offered by Syneos Health include:

• Decentralized Clinical Trials Solutions
• Bioanalytical Solutions
• Phase II-III/Phase IIIb-IIIV
• Medical Device Diagnostics
• Clinical Data Management
• Clinical Project Management
• Clinical Monitoring
• Drug Safety & Pharmacovigilance
• Site and Patient Access

6. Labcorp Drug Development (Formerly Covance)

Formerly known as Covance and renamed to Labcorp Drug Development in early 2021, this CRO is one of the largest contract research organizations in the world. The company claims to provide the world’s largest central laboratory network, and has been rated as one of the best places to work for LGBTQ+ equality by the Human Rights Campaign organization in 2018 to 2021. Currently, Labcorp employs over 70,000 people and is able to support clinical research efforts in almost 100 countries around the world.

Some clinical trial solutions offered by Labcorp Drug Development include:

• Preclinical Services
• Clinical Trials
• Clinical Trial Laboratory Services
• Post-Marketing Solutions
• Medical Devices
• Data & Technology

Also known as Pharmaceutical Product Development, PPD is a large global contract research organization headquartered in Wilmington, North Carolina. Started as a one-person consulting firm in 1985, PPD has grown to over 27,000 employees worldwide, and provides a wide range of clinical research services to pharmaceutical and biotech companies.

Some clinical trial solutions offered by PPD include:

• Clinical Development
• Early Development
• Peri- and Post-Approval
• PPD Biotech
• PPD Laboratories
• Product Development and Consulting
• Site and Patient Centric Solutions

8. Fisher Clinical Services

Part of Thermo Fisher Scientific, Fisher Clinical Services is a global clinical research organization with headquarters in Center Valley, Philadelphia.

The company has been in the business of clinical supply chain management for over 20 years, and is focused exclusively on working with the packaging and distribution requirements of clinical trials across the globe.

Some clinical trial solutions offered by Fisher Clinical Services include:

• Biologistics Management
• Cell & Gene Therapy
• Clinical Ancillary Management
• Clinical Label Services
• Clinical Trial Packaging & Storage
• Clinical Supply Optimization Services
• Cold Chain Management & Expertise
• Direct-to-Patient
• Distribution & Logistics
• Strategic Comparator Sourcing
• Public Health Research

Established in 1997 under the name Kiecana Clinical Research, KCR is a full-service contract research organization that provides a variety of services for clinical monitoring, safety & pharmacovigilance, clinical project management, quality assurance and regulatory affairs.

KCR operates globally, and has offices in North America, Western Europe, Central Europe and Eartern Europe. The company currently employs more than 700 staff.

Some clinical trial solutions offered by KCR include:

• Trial Execution

10. Medpace

Founded in 1992 and based in Cincinnati, Ohio, Medpace is a midsize clinical contract research organization. The company has operations in over 45 countries, and employs over 2,800 people. Medpace provides support services for Phase I-IV clinical trials for pharmaceutical and biotechnology companies, which include central laboratory services and regulatory services.

Some clinical trial solutions offered by Medpace include:

• Biostatistics and Data Sciences
• Clinical Trial Management
• Drug Safety and Pharmacovigilance
• Medical Writing
• Quality Assurance
• Regulatory Affairs
• Risk-Based Monitoring
• Medpace Laboratories

11. Clintec

Now in business for over 22 years, Clintec is a medium-sized global contract research organization for pharmaceutical, biotech and medical device industries, with large expertise in oncology and rare diseases.

The company provides the flexibility and agility of a smaller-sized CRO, while also having a wide global coverage that large CRO companies are known for. Clintec is based in more than 50 countries, and was acquired by the leading global CRO IQVIA in late 2018.

Some clinical trial solutions offered by Clintec include:

• Project Management
• Data Management
• Biostatistics
• Global Feasibilities
• Patient Recruitment & Retention

12. Worldwide Clinical Trials

Bringing over 30 years of experience to the clinical research market, Worldwide Clinical Trials is a leading medium-sized global contract research organization. Founded by physicians with a dedication and commitment to advancing medical research, Worldwide Clinical Trials was the first customer-centric CRO.

Currently the company has coverage in more than 60 countries, and has extensive experience in a wide range of therapeutic areas, including central nervous system, metabolic, cardiovascular, oncology, rare diseases and general medicine.

Some clinical trial solutions offered by Worldwide Clinical Trials include:

• Bioanalytical Lab
• Early Phase Development
• Clinical Phase IIB-II Clinical Trials
• Phase IIIB-IV Clinical Trials
• Trial Management Technologies

Named #1 CRO in the world for operational excellence at the 2021 CRO Leadership Awards, CTI Clinical Trial And Consulting Services is a medium-sized global contract research organization that has been serving pharmaceutical companies since 1999.

Based in Covington, Kentucky, CTI has offices around the world in more than 60 countries, with coverage in North America, Europe, Latin America, Middle-East, Africa, and Asia-Pacific regions.

Some clinical trial solutions offered by CTI include:

• Feasibility
• Regulatory Affairs Study Start-Up
• Medical Monitoring
• Safety & Pharmacovigilance
• Clinical Services

14. Wuxi AppTec

Founded in 2000 as WuXi PharmaTech in the city of Wuxi, China, Wuxi AppTec has grown from a single laboratory into a leading global contract research organization with more than 28,000 employees, including 23,000 scientists and more than 30 research & development and manufacturing sites around the world.

With offices in Asia, U.S, Europe and the Middle East, the company is able to provide coverage to more than 30 countries around the world.

Some clinical trial solutions offered by Wuxi AppTec include:

• Small Molecule Drug R&D and Manufacturing
• Cell Therapy and Gene Therapy
• Drug R&D and Medical Device Testing
• Clinical Services (Phase I-IV)

15. Advanced Clinical

Founded in 1994 and based out of Deerfield, Illinois, Advanced Clinical is a midsize and full-service CRO that helps sponsors with running clinical trials. The company employs more than 700 staff, and offers a wide variety of services across many therapeutic areas. Advanced Clinical has global representation in over 50 countries around the world.

Some clinical trial solutions offered by Advanced Clinical include:

• eTMF & Document Management
• Global Medical Services
• Quality & Validation

16. Pharm-Olam

Pharm-Olam is a leading midsize CRO with global headquarters located in Houston, Texas and its European headquarters in Bracknell, United Kingdom. The company employs more than 800 staff, and has 25 offices around the world, with a global coverage in more than 60 countries.

The company has therapeutic expertise in 5 areas, including Rare & Orphan Disease, Infectious Disease & Vaccine, Oncology-Hematology, Allergy and Autoimmune.

Some clinical trial solutions offered by Pharm-Olam include:

• Study Feasibility
• Site Activation
• Patient Recruitment
• Medical Affairs
• Compliance & Training
• Clinical Monitoring & Operations

17. Clinipace

Founded in 2003 and based out of Morrisville, North Carolina, Clinipace is a global midsize full-service CRO with a focus on solution customization for clinical trials. The company has a large global coverage in more than 50 countries, and has offices in North America, South America, Europe and Asia-Pacific regions.

Clinipace’s therapeutic focus areas include Oncology, Nephrology and Urology, Rare Disease, Gastroenterology and Women’s Health. The company also has complete therapeutic expertise in Infectious Disease & Vaccines, Cardiology, CNS, Immunology, and Respiratory.

Some clinical trial solutions offered by Clinipace include:

• Clinical Analytics
• Clinical Technology and Ecosystem
• Functional Service Partnership (FSP)
• Regulatory & Strategic Product Development

9 Fundamental Questions To Ask A Top CRO Company Before Signing The Contract

1. which services does the cro provide.

CROs offload a lot of operational tasks from trial sponsors, which can touch any component of clinical trial operations. From formulating an overall study strategy and implementing technologies to support the operational processes of the trial, to picking and identifying sites, and supporting patients during the trial, the range of clinical services offered by a CRO tends to be vast and inclusive of all the typical services and support you will require for running a successful clinical trial.

However, not all CROs are the same in their service offerings, or are able to offer the same depth of capability within a seemingly same clinical trial support process. For this reason it is important to understand exactly which kind of clinical services and support you are looking to receive from the prospective CRO when running your clinical trial.

While services such as clinical monitoring and clinical trial management are offered by the majority of CROs, the specific needs of each trial are unique, and for this reason it is important to first identify what will be the unique services your trial requires. Completing this internal analysis first will help you to understand the extent to which a potential CRO partner will be able to provide all of these services.

Some CROs specialize in specific clinical trial functions which the company may label as a “core services”, in which case this is a sign the company will have more expertise, experience, and will be set up in a way to maximize their capabilities in providing support for these services compared to other services that the CRO offers.

For example, a CRO may include patient recruitment as part of its “core services”, which implies that they are highly skilled in and have the necessary infrastructure to design and implement a high-quality patient recruitment strategy.

Clara Health CRO Support Services: At Clara Health our specialty services include technology-augmented digital and patient advocacy recruitment, as well as patient support via our signature patient recruitment platform, which we use to upgrade clinical trials and deliver results sponsors look for in their recruitment and retention campaigns.

At Clara, we work alongside CROs to supplement and support clinical trials with modern and personalized capabilities that CROs do not typically have the bandwidth, corporate structure or infrastructure to support.

If you would like to learn more about exactly how our platform can upgrade your unique trial, feel free to book a Free 30 Minute Consultation Session Here with one of our in-house experts.

2. What Related Experience Does The CRO Have?

It is helpful to ask the prospective CRO company if they have any relevant experience in running clinical trials that would be an asset in designing and running your study. Previous experience in a related therapeutic area or in running a trial with a similar design allows CROs to have a deeper understanding into potential opportunities and challenges, increasing the likelihood of your clinical study being successful.

For example, if a sponsor is planning to run a trial in oncology, for the purpose of site identification and selection it would be valuable to partner with a CRO vendor that has expertise in this area, as they likely already have a good understanding of which sites will lead to optimal results.

However, it is also important to consider all factors when selecting a CRO vendor and not to rely on therapeutic experience as the sole qualifier for whether or not a potential CRO is a fit for your trial. While previous experience is beneficial, some sponsors close themselves off from working with vendors that have not worked in their therapeutic area, which significantly limits options when choosing a CRO partner that is truly a good fit for their clinical study.

This can impact the end result of your clinical study, as sponsors that are not successful in choosing a CRO vendor that is the right overall fit may face difficulties if the needs of their clinical study aren’t being properly met.

Clara Health: We have worked to provide support for clinical trials across a wide range of therapeutic areas and trial designs. Our specialty is filling in the gaps that CROs traditionally did not have to think about, which include digital patient recruitment, patient advocacy recruitment, and technology-augmented patient support.

Additionally, we are constantly building our proprietary data and running tests in a variety of therapeutic areas. These research efforts allow us to have a detailed understanding of the expected level of difficulty when recruiting particular patient populations, as well as allow us to predict with accuracy which segments of the targeted population will be likely to qualify in a particular study.

3. What Are The Communication Workflows & Expectations For Performing And Delivering Contracted Services?

It is important that you clarify what the expectations for communication will be between your prospective CRO vendor and your internal teams, as you will most likely be working with the CRO of your choice for the entire duration of your clinical trial.

There are a vast variety of factors and success determinants for a clinical trial, which are continuously undergoing change as the study unfolds. For this reason, it is recommended that you work with a CRO that is proactive in their communication, so that you are kept up to date with information about important changes as your clinical trial progresses.

A vendor that is proactive rather than reactive in their communication and approach to dealing with arising issues is one of the most important qualities in CRO. Challenging situations will naturally arise, and the promptness with which they are taken care of will significantly impact your clinical trial’s degree of success. Therefore, seeking a vendor that is able to match the standard of communication that you as a sponsor would like to experience throughout the duration of your partnership is one of the most critical steps in determining which CRO is the right fit for your clinical trial.

We’ve included a few additional questions pertaining to the communication structure and reporting expectations that you can ask a prospective CRO vendor to determine the degree of fit in this particular category:

Communication Expectations:

• If we were to move forward with you, which of your team members will be our main point of contact?
• How available will you be outside of the scheduled meetings to address any of our concerns or additional requests?
• What will be the frequency at which update meetings will be conducted, and who will be present at those meetings?
• Which clinical study processes will be reported on, and what will be the workflow for how we will receive this information?
• What will be the cadence at which we will receive progress reports?
• Would we be able to access metrics electronically via an interactive dashboard, or will you send us formal reports?

Clara Health: At Clara Health, we directly interact and actively work with several key stakeholders involved in running a clinical trial, which includes sponsors, CROs, sites, and patients. This unique position allows us to have a centralized perspective which helps us to see all the moving parts of a clinical trial at the same time, which helps to identify issues and relay this vital information and insight back to the sponsor (or other appropriate stakeholders) in the shortest time possible.

The ability to access this perspective allows us to gather the most accurate, complete, and up-to-date information about how the clinical trial is unfolding, and quickly becomes very valuable to sponsors for their clinical trial.

As an example, we may receive feedback from patients about having an unsatisfactory experience with a particular study site. We are able to aggregate and analyze this information, and relay our findings back to the sponsor and the study site to improve the experience for other patients.

4. What Is The CRO’s Client Satisfaction Record?

It is a good practice to request information or metrics from the prospective CRO vendor that can point to the degree of satisfaction of their past clients. Prior to signing the contract, vendors will naturally do their best to uplift their image and future value to you during their sales conversations with you and your team. It can be tricky to get an objective understanding of what the partnership experience will actually entail, especially when there are multiple vendors fighting for your commitment.

We recommend that you ask the prospective vendor to provide success metrics regarding areas of clinical trial operations that are going to be important for your trial.

For example, you may be interested in learning about the vendor’s relationship to finances, in which case it will be useful to ask them about situations in which they went over the planned budget, and investigate into the reasons behind that. Alternatively you may be concerned about potential delays in timelines, in which case it would be helpful to learn about metrics regarding the CRO’s ability to meet timeline expectations.

You may also request to talk to the prospective CRO’s past clients, which will help you to gain insight into what the relationship was like and give you the opportunity to examine if the way in which the particular CRO manages its relationships and performs its services meets the expectations that you would have for your potential relationship and for your clinical trial.

Clara Health: At Clara Health, our relationships with our partners and with our patients are most important to us. In the unique position where we fit in the clinical trial process, we have the opportunity to directly co-create the clinical trial patient experience with a variety of stakeholders, including sponsors, sites, CROs, and patients.

Our company’s values and culture have been directed and developed to be such that the client and patient experience is at the top of priority for all of our internal teams, and we work to provide the best quality of care to all stakeholders.

We have many testimonials from every type of partner we’ve worked with which we can happily share with you.

5. How Do You Adapt When Encountering Challenges With Running A Clinical Trial?

It is inevitable that challenges and unforeseen changes will arise throughout the operational clinical trial process, and for this reason it is important to work with a CRO vendor that can provide you with evidence of their flexibility and ability to adapt to sudden changes.

The ideal CRO partner is one that is highly consultative throughout the entire process, and has an ability and the initiative to deal with challenges at their seed stage, prior to them turning into major obstacles for the success of your trial.

CROs naturally have a large reach, and there are a lot of different clinical trial mechanisms and processes that are under their control. They are able to monitor and respond to what is going on in every key link in the chain of the clinical trial operation.

It is reasonable to expect this level of oversight from a CRO, and additional questions that can help you gain insight into this include:

• What are some examples where the CRO was effective at monitoring the health of clinical trials they’ve helped operate in the past?
• How quickly does the CRO respond to challenges or opportunities for improving the clinical trial experience?
• How well does the CRO gather & process information from study sites, study teams, patients & the sponsor, and what are their typical data analysis workflows?

It is also recommended to speak to the prospective CROs past clients to help you gain insight into how well they respond and adapt to the naturally arising challenges in clinical trials.

Clara Health: While CROs do have a large reach within the clinical trial, no CRO has complete visibility into every clinical process. They are not typically set up to support full visibility, which can manifest as a potential threat to your clinical trial as it unfolds. This is especially true for parts of the clinical trial processes that CROs naturally do not specialize and often subcontract, such as clinical trial recruitment.

At Clara, we are in a unique position in relation to other key partners involved in operating the clinical trial. We are in direct and frequent contact with patients, CROs, study sites, study teams, and the sponsor, and have a very deep understanding of the patient pipeline. This allows us the unique ability to go very deep into specific parts of the recruitment chain and investigate what is working and what is not working.

In addition, Clara functions as a resource for all partners in the clinical trial. For example, we work directly with site teams to ensure that they have access to a 3rd party that they can relay their needs to and receive fast support in case there is anything they require that can improve the patient recruitment process.

6. Which Parts Of Operating The Clinical Trial Will You Be Outsourcing?

Since there are so many processes and mechanisms that go into operating a clinical trial, CROs will always outsource some parts of running and managing the study. While you can expect that the prospective CRO will subcontract some of the work, it is important to find out which exact parts the clinical study will be outsourced.

There are certain basic and key clinical processes (such as site selection) that CROs almost always help with, and if you find that these parts of your trial are going to be subcontracted to another company, it is recommended to find out why the CROs operations are set up this way and how this would impact the service you will receive.

Ultimately what matters to you as a partner and client is that the quality of service and care that you will receive will be up to standard, and meet what was promised and what you are expecting. While this trust is important after you have signed the contract, it is recommended that prior to entering into such a significant commitment that you have evidence and the conviction that the CRO of your choice is truly the right fit and will deliver the quality of service that was being discussed.

Since it is impossible to predict exactly what the quality of this relationship and services performed will actually be like in practice, it is recommended that you understand the details of what will be done for your trial and how. Investigating how the CRO outsources and subcontracts services for a clinical trial will help you to gain necessary insight that you would need to make the correct vendor selection decision.

Clara Health: At Clara, we maximize the effectiveness of the digital component across the entire digital & recruitment spectrum, which is added on top of the existing capabilities of the CROs and other vendors involved in operating your clinical trial. In addition, we offer services that augment the CROs efforts, which has the potential to significantly improve the patient experience, operations flows, recruitment and retention performance, which is so important in ensuring the success of a clinical trial.

For example, if a CRO wants to have a great site relationship, we are able to come in as a third party on behalf of the sponsor and CRO and act as a resource and additional support for sites.

In another example, If a sponsor wants to have great relationships with the patient community, Clara is able to come in on behalf of the sponsor and develop these relationships while being perceived more neutrally by the patient community.

7. Do You Have Experience Running International Trials?

If you are planning on operating an international clinical trial, it is recommended to work with a CRO that has extensive experience in this area. While many CROs will offer near-global coverage, the level of experience with specific geographic locations can significantly vary from one vendor to another.

It is important to work with a CRO that has experience running clinical trials in the specific countries and regions you are planning to conduct your research in. Being compliant with the local rules and regulations for clinical testing is a very complex process that requires existing understanding and familiarity in order to ensure logistical smoothness and to mitigate legal risks. In operating a clinical trial, there are a multitude of clinical services and processes, which can greatly vary across the many regions in which you can conduct clinical testing.

A CRO that is lacking experience in operating international trials or operating in particular regions where you plan on conducting research may not be able to meet your desired quality and agility expectations, and therefore may not be the right fit for your international clinical trial.

Clara Health: In the past, we have provided international patient recruitment and digitally-augmented trial support services for clinical trials in the EU, Canada, UK, Australia and South America.

Clara Health is fully compliant to operate international studies everywhere in the world, with the exception of Russia and China.

8. What Is Your Relationship With Patients?

Patient-centric approach to designing and operating a clinical trial is becoming more and more crucial in the clinical research space. The ability of a sponsor and their CRO partner to understand the needs and characteristics of their target patient community is a significant determinant of whether or not the study will be a success.

A sponsor that has close and authentic relationships with the patient community tends to have a deeper understanding of how to create the best clinical trial experience that will attract patients and keep their interest throughout the clinical trial.

In addition, strong relationships with patients allow sponsors and CROs to forecast recruitment and patient retention pipeline with much higher accuracy. This ability is critical for ensuring the success of the trial and mitigating the risk of low enrollment. After an understanding of the patient population is acquired, sponsors gain the necessary insight to design a clinical trial that is not only favorable to their research results, but is also practical and will result in the enrollment numbers they are looking for.

While many CROs have already recognized the importance of patient-centricity and evolved the ways in which they design and operate clinical trials, other CROs have not yet made such a pivot in their values. It is important to understand the degree of importance the prospective CRO places on creating a favorable patient experience, and what kind of infrastructure the company has to support it.

At Clara, we recommend choosing a CRO partner that is adapting to the patient-centric model which is becoming more and more important for running a successful clinical trial.

Clara Health: Since early stages of our development, we’ve had a dedicated patient advocacy team that has been integral in shaping our company’s vision and operations. We have built our entire platform and recruitment infrastructure around creating the best experience for patients. Our teams, corporate values, service offerings and company infrastructure all work in the service of the patient.

In addition, over the many years of being in business we have heavily invested in building authentic patient community relationships that span across a variety of therapeutic areas. This has given us a unique ability to receive feedback directly from patients that is genuine and authentic around marketing materials, strategy for patient recruitment, and other services that we build for specific trials.

This ability to build partnerships with the patient community in an authentic way gives us a very unique ability to engage with the patient community on behalf of a pharmaceutical company, allowing our sponsor & CRO partners the opportunity to start conversations with patients through our in-house patient advocacy team.

If you would like to learn how Clara can help you to build a strong & authentic relationship with your target patient community, get in touch with us and we’d be happy to share our capabilities and previous results with you as they relate to your current or upcoming clinical trial.

9. How Is The CRO Going To Utilize Patient Input For Developing The Trial?

In the initial stages of clinical trial design, sponsors often determine the ideal patient profiles that would help them to drive the most favorable research outcomes for their study. While it is important for the success of your trial to determine who your ideal patients are, very often these projections do not match up with what is viable in practice.

At Clara, we often encounter study protocols that are not set up realistically for successful recruitment to be possible.

Common mistakes that are made when determining trial eligibility criteria and trial design include:

• Overestimating the interest in the clinical trial from the target patient population
• A lack of patient focus in the trial design
• A lack of convenience for patients in their participation
• Complicated and/or inefficient study experience flows
• Crafting the eligibility criteria around the patient population that is most likely to lead to favorable study outcomes, without conducting sufficient research to more accurately estimate the recruitment and retention difficulty of the group for a particular study

It is natural for there to be a “push & pull” between the research ideal and the real world practicality. It is important to determine the correct balance between these two sides for your trial, as going too far in either direction will decrease the chance of your clinical study’s success.

The nature of the industry as it is right now is such that there is excess research idealization and not enough emphasis on patient centricity. This distorted orientation has resulted in many clinical trials being unsuccessful, negatively impacting sponsors, patients and the entire clinical trials industry.

The ideal CRO partner should help you make sure that your protocol design sets your study up for success. The CRO should be able to help you determine the proper balance between the research ideal and the real world practicality, and back up their findings with sufficient research and patient data that can project your trial being a success.

Clara Health: When formulating a recruitment and retention plan for our clients, we begin with conducting thorough research into the target trial patient population. This allows us to get a clear understanding of which recruitment channels will yield the best results and what kind of marketing materials will resonate with the prospective study participants.

To ensure accuracy and real-world applicability of our research, we consult and collaborate with our internal patient advocacy and patient support teams, as well as with our clients and patients representing the target trial patient profiles. We then tie our findings back with any existing proprietary data that we have in connection with the therapeutic area or the prospective target patient group.

Our unique position within the clinical recruitment chain gives us the presence and deep-rooted access needed to effectively tap into any of the three patient traffic sources: digital recruitment, offline recruitment, or patient advocacy recruitment.

Once a recruitment campaign has gone live, we constantly monitor, analyze and optimize our performance to make sure that the processes we have in place are as efficient as possible and drive the greatest results. In addition, we have the capability to layer in any traditional advertising (such as billboard ads) if requested by the study sponsor.

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• Clinical Trials: What Patients Need to Know

Basics About Clinical Trials

What are clinical trials.

Clinical trials are research studies in which people volunteer to help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

Clinical trials are conducted according to a plan, called a protocol, which describes:

• the types of patients who may enter the study
• the schedules of tests and procedures
• the drugs involved
• the dosages, or amount of the drug
• the length of the study
• what the researchers hope to learn from the study.

Volunteers who participate in the study must agree to the rules and terms outlined in the protocol. Similarly, researchers, doctors, and other health professionals who manage the clinical trials must follow strict rules set by the FDA. These rules make sure that those who agree to participate are treated as safely as possible.

Learn more about the basics of clinical trial participation, read first hand experiences from actual clinical trial volunteers, and see explanations from researchers at the NIH Clinical Research Trials and You Web site.

Why are clinical trials done?

Clinical trials are conducted for many reasons:

• to determine whether a new drug or device is safe and effective for people to use.
• to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
• to learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.

Who should consider clinical trials and why?

Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.

Ensuring people from diverse backgrounds join clinical trials is key to advancing health equity. Participants in clinical trials should represent the patients that will use the medical products. This is often not the case—people from racial and ethnic minority and other diverse groups are underrepresented in clinical research. This is a concern because people of different ages, races, and ethnicities may react differently to certain medical products. Learn more about the clinical trial diversity initiative from the Office of Minority Health and Health Equity.

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.  FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials. Learn more about FDA’s efforts to increase diversity in clinical trials .

Where are clinical trials conducted?

Clinical trials can be sponsored by organizations (such as a pharmaceutical company), Federal offices and agencies (such as the National Institutes of Health or the U.S. Department of Veterans Affairs), or individuals (such as doctors or health care providers). The sponsor determines the location(s) of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

Are clinical trials safe?

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

What should I think about before joining a clinical trial?

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:

• what happens during the trial
• the type of health care you will receive
• any related costs once you are enrolled in the trial
• the benefits and risks associated with participating. 

What is FDA’s role in approving new drugs and medical treatments?

FDA makes sure medical treatments are safe and effective for people to use. We do not develop new therapies or conduct clinical trials. Rather, we oversee the people who do. FDA staff meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data.

Learn more about the Drug Development Process .

Where can I find clinical trials?

One good way to find out if there are any clinical trials that might help you is to ask your doctor. Other sources of information include:

• FDA Clinical Trials Search. Search a database of Federally and privately supported studies available through clinicaltrials.gov. Learn about each trial’s purpose, who can participate, locations, and who to contact for more information.
• Clinicaltrials.gov. Conduct more advanced searches
• National Cancer Institute or call 1–800–4–CANCER (1–800–422–6237). Learn about clinical trials for people with cancer.
• AIDS Clinical Trials and Information Services (ACTIS) or call 1–800–TRIALS–A (1–800–874–2572). Locate clinical trials for people with HIV.
• AIDSinfo. Search a database of HIV/AIDS trials, sponsored by the National Institutes of Health’s National Library of Medicine.

What is a placebo and how is it related to clinical trials?

A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.

Is there a chance I might get a placebo?

In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and how is being treated with the experimental drug. Many cancer clinical trials, as well as trials for other serious and life-threatening conditions, do not include placebo control groups. In these cases, all participants receive the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you.

How do I find out what Phase a drug is in as part of the clinical trial?

Talk to the clinical trial coordinator to find out which phase the clinical trial is in. Learn more about the different clinical trial phases and whether they are right for you.

What happens to drugs that don't make it out of clinical trials?

Most drugs that undergo preclinical (animal) research never even make it to human testing and review by the FDA. The drug developers go back to begin the development process using what they learned during with their preclinical research. Learn more about drug development .