clinical research company meaning

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.

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

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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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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Selecting a CRO

WHAT IS A CRO?

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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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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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CROs are recognized as strategic partners for sponsors seeking to manage and conduct clinical trials efficiently. They assist in study design, which involves determining the research objectives, defining the study population, and selecting appropriate endpoints and outcome measures. CROs bring their expertise in research methodology and regulatory requirements to help sponsors design studies that are scientifically rigorous and aligned with regulatory expectations.

Does a CRO assist with trial site selection?

Site selection is another crucial aspect of CRO operations. CROs evaluate potential trial sites based on factors such as patient population, infrastructure, and investigator experience. By conducting thorough assessments, CROs ensure that the selected sites have the necessary capabilities to execute the trial effectively and recruit eligible patients. This process significantly contributes to the successful implementation of clinical trials.

Is patient recruitment part of the CRO remit?

Patient recruitment is often a significant challenge in clinical research. Working with sites, CROs employ various strategies to optimize patient recruitment , such as implementing targeted advertising campaigns, utilizing patient databases, and collaborating with healthcare providers and patient advocacy groups. By employing these approaches, CROs help sponsors enroll the desired number of participants within the designated time frame, ensuring that the trial progresses as planned.

What is covered in the data management process?

Data management is a critical component of clinical trials, and CROs play a vital role in ensuring the integrity and accuracy of data collected. They develop comprehensive data management plans, which include processes for data collection, cleaning, validation, and storage. CROs also leverage advanced technologies and systems to streamline data collection and facilitate real-time access to study data, enabling timely analysis and decision-making.

Does the CRO manage site monitoring?

Monitoring is an essential aspect of clinical trials, and CROs conduct regular visits to trial sites to assess protocol adherence, data accuracy, and patient safety. These visits, known as monitoring visits, involve reviewing source documents, verifying data against case report forms, and identifying and addressing any deviations or issues. Through monitoring, CROs ensure that the trial is conducted in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements.

Is regulatory compliance a key feature of CRO services?

Regulatory compliance is a fundamental responsibility of CROs, who navigate the complex regulatory landscape governing clinical research. They ensure that trials adhere to local regulations, international guidelines, and ethical standards. CROs maintain regular communication with regulatory bodies, facilitating the submission of necessary documentation and approvals. By upholding regulatory compliance, CROs ensure the reliability and validity of trial results.

Does the CRO service include overall project management?

Project management is a crucial function provided by CROs, encompassing the coordination and oversight of all trial activities. CROs develop comprehensive project plans, establish timelines, allocate resources, and monitor progress to ensure the smooth execution of clinical trials. Effective project management ensures that trials are conducted efficiently, within budget, and according to the predefined timelines.

Does the CRO manage data analysis?

Data analysis is a critical step in clinical research, and CROs possess expertise in statistical analysis and interpretation. They employ advanced statistical methods to analyze trial data, generate insights, and draw meaningful conclusions. Through data analysis, CROs contribute to the evaluation of treatment efficacy, safety profiles, and patient outcomes, ultimately supporting evidence-based decision-making.

What is covered in pharmacovigilance?

Pharmacovigilance is an integral part of CRO operations, focusing on the detection, assessment, understanding, and prevention of adverse events associated with investigational drugs. CROs develop robust pharmacovigilance systems and processes to ensure the ongoing safety monitoring of trial participants. By promptly identifying and reporting adverse events, CROs contribute to the overall safety and well-being of study subjects.

Does the CRO manage regulatory submissions?

Regulatory affairs form a crucial aspect of CRO services, involving the compilation and submission of regulatory documents to obtain necessary approvals from regulatory authorities. CROs assist sponsors with global regulatory writing and consulting , preparing regulatory submissions, including investigational new drug applications, ethics committee approvals, and clinical study reports. Their knowledge of regulatory requirements and expertise in document preparation streamline the approval process, enabling timely initiation and completion of clinical trials.

The global landscape of CROs is marked by their presence in various regions across the globe. CROs have the expertise to navigate local regulations, cultural nuances, and language barriers. This global reach enables them to conduct multinational trials, ensuring the inclusion of diverse patient populations and enhancing the generalizability of trial results.

The CRO industry is witnessing emerging trends that are shaping the future of clinical research. The integration of digital technologies, such as electronic data capture systems, remote monitoring solutions, and wearable devices, has revolutionized data collection and patient engagement. These technologies enhance the efficiency and accuracy of data capture, minimize errors, and improve the overall patient experience.

What is RWE?

Real-world evidence (RWE) utilization is gaining prominence in the CRO industry. CROs leverage RWE, which includes data from real-world settings, such as electronic health records and claims databases, to complement traditional trial data. By incorporating RWE, CROs enhance the understanding of treatment effectiveness, safety profiles, and patient outcomes in real-world populations, providing a comprehensive view of therapeutic interventions.

What is adaptive trial design?

Adaptive trial designs are becoming increasingly prevalent in clinical research, allowing trials to be modified and optimized in real-time based on accumulating data. CROs embrace adaptive trial designs, enabling sponsors to make data-driven decisions, refine study protocols, and enhance trial efficiency. These designs maximize the use of resources, reduce timelines, and improve the likelihood of trial success.

CROs are instrumental in advancing clinical research and the development of new therapies. Through their multifaceted services, including study design, site selection, patient recruitment , data management, monitoring, and regulatory affairs, CROs ensure the highest standards of quality, safety, and ethical conduct in clinical trials. They play a pivotal role in accelerating the drug development process, improving efficiency, and reducing costs for sponsors. As the global landscape of clinical research continues to evolve, CROs navigate local regulations, embrace emerging trends, and leverage advanced technologies to drive innovation and contribute to the translation of scientific discoveries into tangible benefits for patients worldwide.

Therapeutic Expertise

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HOW WE DO IT

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Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.

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Cross-Therapeutic Expertise

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Our experts help you stay at the forefront of the industry - and ahead of change.

New Medicines, Novel Insights

• Advancing rare disease drug development
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Discussions on Diversity

• Chapter 1 Bridging the Gap
• Chapter 2 Beyond the Binary

The Regulatory Navigator

• BIOSECURE Act: Implications for US-based drug developers
• Exploring ICH Q5A revision 2
• Potency assurance for CGT products: FDA's new draft guidance

Latest Report

New Medicines, Novel Insights: Achieving patient-guided drug development

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HEAR FROM REAL PATIENTS

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TRIAL SITES

Want to collaborate with us to offer clinical trials at your site? We would welcome the opportunity to discuss.

We are one of the largest CROs in the world, speeding life-changing medicine to market by engaging patients With Heart ™. Learn about who we are, what we do, and what we believe.

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• 17th ISCR ANNUAL CONFERENCE 2024
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• Final countdown: How to transition your trials under EU-CTR
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What can we help you find today?

The perspectives and opinions expressed in this material represent those of the patient advocate only and should not be considered a solicitation, promotion or advertisement for any services of Parexel, or any drugs or therapies, including those under development. Participating in clinical trials for investigational medicines offers patients potential benefits, such as access to cutting-edge treatments and expert medical care, while contributing to medical research. However, risks may include side effects, unpredictable outcomes, and time commitment. Careful assessment of these factors helps patients make informed decisions. The content of this material, including graphics, images and text, is provided for informational purposes only and does not constitute medical advice, diagnosis or treatment. Please consult your healthcare professional for medical advice. The patient advocate has provided their consent for the use and distribution of this content.

Patient Story

• Rare Diseases
• Inflammation & Immunology
• Cell & Gene Therapy

Sara's only symptom was fatigue. But after some routine tests, she was diagnosed with breast cancer.

Now she was the one in need of care — joining the 3.8 million women in the US and many others around the world impacted by breast cancer.

For years she'd worked at a hospital, onboarding new doctors and making care possible for others.

Now she was the one in need of care — joining the 3.8 million women in the US and many other around the world impacted by breast cancer.

She started radiation. A new, promising chemotherapy treatment was also available, so she joined the clinical trial.

That decision changed her life., today, she’s cancer free — and works at parexel to help ensure our trial sites are prepared to meet the needs of patients like her., lives can change when you design oncology trials with speed and precision..

• Utilize the right experts, with the right specialization
• Find the patients you need and earn their trust
• Satisfy global regulations to get your treatment to patients safely and quickly
• Design studies and endpoints with market access in mind

What we do, we do

Our Experts

Our oncology specialists collaborate to help get your treatment to patients like Sara faster.

MORE EXPERTS

Scott Smith, M.D., Ph.D.

Senior Vice Presiden...

Allen Zhong, M.D., Ph.D.（钟飞）

Vice President, Onco...

Claudia Marques Vasconcelos

Global TA Section He...

Floris Höppener, M.D.

Gamal ElSawah, M.D.

Maria Cristina Villarroel

Ondrej Krejci

Senior Medical Direc...

Allen Zhong (钟飞)

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Amy McKee, M.D.

Chief Medical Officer and Global Head, Oncology Center of Excellence

With 11 years of experience from the FDA, Amy provides patient-focused medical and scientific leadership globally at Parexel. She’s an energetic leader with demonstrated ability to build and lead multidisciplinary teams, utilizing novel endpoints and incorporating real-world evidence to accelerate clinical development.

"What differentiates us is that we have that expertise globally. We have experts in Europe. We have experts in Asia. We have experts in the Americas. And so we can cover every region with the kind of expertise that you need for your study."

Our oncology team is 1,000+ strong, with experience across the oncology continuum, to match the needs of your trial.

Advanced modeling and simulation allow us to predict drug effects in advance , saving time, money, and resources.

Our experience with oncology clinical trial sites around the world allows us to accelerate study start-up.

• North America
• South America
• Middle East & Africa

Our application of real-world data allows us to find the right study participants fast.

Our global regulatory team keeps everything running smoothly.

And our patient-first approach results in deeper, more relevant insights for trial design and execution.

BENEFITS MAY INCLUDE

What can we do to help you change patient lives?

See oncology capabilities Visit all therapeutic areas Explore oncology careers

Want our latest insights for oncology?

Ready to speak to someone on our team?

Are you a patient interested in a clinical trial?

We focus on patients, because they inspire us to deliver better trials, faster than ever . So we can make a difference for more patients like Sara.

Who we are,, parexel is proudly among the world’s largest clinical research organizations.

A dedicated CRO providing the full range of Phase I to IV clinical development services  and leveraging the breadth of our clinical, regulatory and therapeutic expertise , our team of more than 21,000 global professionals works in partnership with biopharmaceutical leaders and sites to design and deliver clinical trials with patients in mind , to make clinical research a care option for anyone, anywhere.

Clinical Research Organizations

• First Online: 19 November 2022

Cite this chapter

• Gregory A. Hale 6 &
• Jennifer Pullum 7  

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

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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.

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Hale, G.A., Pullum, J. (2022). Clinical Research Organizations. In: DiMartino, J., Reaman, G.H., Smith, F.O. (eds) Pediatric Cancer Therapeutics Development. Pediatric Oncology. Springer, Cham. https://doi.org/10.1007/978-3-031-06357-2_8

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Nih clinical research trials and you, what is clinical research.

Clinical research occurs in many formats and can involve anyone. Learn how you can participate and contribute to medical advances.​

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Research: it's all about patients.

Mayo's mission is about the patient, the patient comes first. So the mission and research here, is to advance how we can best help the patient, how to make sure the patient comes first in care. So in many ways, it's a cycle. It can start with as simple as an idea, worked on in a laboratory, brought to the patient bedside, and if everything goes right, and let's say it's helpful or beneficial, then brought on as a standard approach. And I think that is one of the unique characteristics of Mayo's approach to research, that patient-centeredness. That really helps to put it in its own spotlight.

At Mayo Clinic, the needs of the patient come first. Part of this commitment involves conducting medical research with the goal of helping patients live longer, healthier lives.

Through clinical studies, which involve people who volunteer to participate in them, researchers can better understand how to diagnose, treat and prevent diseases or conditions.

Types of clinical studies

• Observational study. A type of study in which people are observed or certain outcomes are measured. No attempt is made by the researcher to affect the outcome — for example, no treatment is given by the researcher.
• Clinical trial (interventional study). During clinical trials, researchers learn if a new test or treatment works and is safe. Treatments studied in clinical trials might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments. Find out more about the five phases of non-cancer clinical trials on ClinicalTrials.gov or the National Cancer Institute phases of cancer trials .
• Medical records research. Medical records research involves the use of information collected from medical records. By studying the medical records of large groups of people over long periods of time, researchers can see how diseases progress and which treatments and surgeries work best. Find out more about Minnesota research authorization .

Clinical studies may differ from standard medical care

A health care provider diagnoses and treats existing illnesses or conditions based on current clinical practice guidelines and available, approved treatments.

But researchers are constantly looking for new and better ways to prevent and treat disease. In their laboratories, they explore ideas and test hypotheses through discovery science. Some of these ideas move into formal clinical trials.

During clinical studies, researchers formally and scientifically gather new knowledge and possibly translate these findings into improved patient care.

Before clinical trials begin

This video demonstrates how discovery science works, what happens in the research lab before clinical studies begin, and how a discovery is transformed into a potential therapy ready to be tested in trials with human participants:

How clinical trials work

Trace the clinical trial journey from a discovery research idea to a viable translatable treatment for patients:

See a glossary of terms related to clinical studies, clinical trials and medical research on ClinicalTrials.gov.

Watch a video about clinical studies to help you prepare to participate.

Let's Talk About Clinical Research

Narrator: This presentation is a brief introduction to the terms, purposes, benefits and risks of clinical research.

If you have questions about the content of this program, talk with your health care provider.

What is clinical research?

Clinical research is a process to find new and better ways to understand, detect, control and treat health conditions. The scientific method is used to find answers to difficult health-related questions.

Ways to participate

There are many ways to participate in clinical research at Mayo Clinic. Three common ways are by volunteering to be in a study, by giving permission to have your medical record reviewed for research purposes, and by allowing your blood or tissue samples to be studied.

Types of clinical research

There are many types of clinical research:

• Prevention studies look at ways to stop diseases from occurring or from recurring after successful treatment.
• Screening studies compare detection methods for common conditions.
• Diagnostic studies test methods for early identification of disease in those with symptoms.
• Treatment studies test new combinations of drugs and new approaches to surgery, radiation therapy and complementary medicine.
• The role of inheritance or genetic studies may be independent or part of other research.
• Quality of life studies explore ways to manage symptoms of chronic illness or side effects of treatment.
• Medical records studies review information from large groups of people.

Clinical research volunteers

Participants in clinical research volunteer to take part. Participants may be healthy, at high risk for developing a disease, or already diagnosed with a disease or illness. When a study is offered, individuals may choose whether or not to participate. If they choose to participate, they may leave the study at any time.

Research terms

You will hear many terms describing clinical research. These include research study, experiment, medical research and clinical trial.

Clinical trial

A clinical trial is research to answer specific questions about new therapies or new ways of using known treatments. Clinical trials take place in phases. For a treatment to become standard, it usually goes through two or three clinical trial phases. The early phases look at treatment safety. Later phases continue to look at safety and also determine the effectiveness of the treatment.

Phase I clinical trial

A small number of people participate in a phase I clinical trial. The goals are to determine safe dosages and methods of treatment delivery. This may be the first time the drug or intervention is used with people.

Phase II clinical trial

Phase II clinical trials have more participants. The goals are to evaluate the effectiveness of the treatment and to monitor side effects. Side effects are monitored in all the phases, but this is a special focus of phase II.

Phase III clinical trial

Phase III clinical trials have the largest number of participants and may take place in multiple health care centers. The goal of a phase III clinical trial is to compare the new treatment to the standard treatment. Sometimes the standard treatment is no treatment.

Phase IV clinical trial

A phase IV clinical trial may be conducted after U.S. Food and Drug Administration approval. The goal is to further assess the long-term safety and effectiveness of a therapy. Smaller numbers of participants may be enrolled if the disease is rare. Larger numbers will be enrolled for common diseases, such as diabetes or heart disease.

Clinical research sponsors

Mayo Clinic funds clinical research at facilities in Rochester, Minnesota; Jacksonville, Florida; and Arizona, and in the Mayo Clinic Health System. Clinical research is conducted in partnership with other medical centers throughout the world. Other sponsors of research at Mayo Clinic include the National Institutes of Health, device or pharmaceutical companies, foundations and organizations.

Clinical research at Mayo Clinic

Dr. Hugh Smith, former chair of Mayo Clinic Board of Governors, stated, "Our commitment to research is based on our knowledge that medicine must be constantly moving forward, that we need to continue our efforts to better understand disease and bring the latest medical knowledge to our practice and to our patients."

This fits with the term "translational research," meaning what is learned in the laboratory goes quickly to the patient's bedside and what is learned at the bedside is taken back to the laboratory.

Ethics and safety of clinical research

All clinical research conducted at Mayo Clinic is reviewed and approved by Mayo's Institutional Review Board. Multiple specialized committees and colleagues may also provide review of the research. Federal rules help ensure that clinical research is conducted in a safe and ethical manner.

Institutional review board

An institutional review board (IRB) reviews all clinical research proposals. The goal is to protect the welfare and safety of human subjects. The IRB continues its review as research is conducted.

Consent process

Participants sign a consent form to ensure that they understand key facts about a study. Such facts include that participation is voluntary and they may withdraw at any time. The consent form is an informational document, not a contract.

Study activities

Staff from the study team describe the research activities during the consent process. The research may include X-rays, blood tests, counseling or medications.

Study design

During the consent process, you may hear different phrases related to study design. Randomized means you will be assigned to a group by chance, much like a flip of a coin. In a single-blinded study, participants do not know which treatment they are receiving. In a double-blinded study, neither the participant nor the research team knows which treatment is being administered.

Some studies use an inactive substance called a placebo.

Multisite studies allow individuals from many different locations or health care centers to participate.

Remuneration

If the consent form states remuneration is provided, you will be paid for your time and participation in the study.

Some studies may involve additional cost. To address costs in a study, carefully review the consent form and discuss questions with the research team and your insurance company. Medicare may cover routine care costs that are part of clinical trials. Medicaid programs in some states may also provide routine care cost coverage, as well.

When considering participation in a research study, carefully look at the benefits and risks. Benefits may include earlier access to new clinical approaches and regular attention from a research team. Research participation often helps others in the future.

Risks/inconveniences

Risks may include side effects. The research treatment may be no better than the standard treatment. More visits, if required in the study, may be inconvenient.

Weigh your risks and benefits

Consider your situation as you weigh the risks and benefits of participation prior to enrolling and during the study. You may stop participation in the study at any time.

Ask questions

Stay informed while participating in research:

• Write down questions you want answered.
• If you do not understand, say so.
• If you have concerns, speak up.

Website resources are available. The first website lists clinical research at Mayo Clinic. The second website, provided by the National Institutes of Health, lists studies occurring in the United States and throughout the world.

Additional information about clinical research may be found at the Mayo Clinic Barbara Woodward Lips Patient Education Center and the Stephen and Barbara Slaggie Family Cancer Education Center.

Clinical studies questions

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Clinical Studies in Depth

Learning all you can about clinical studies helps you prepare to participate.

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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 .

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Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington (DC): National Academies Press (US); 2002.

The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary.

• Hardcopy Version at National Academies Press

Appendix V Definitions of Clinical Research and Components of the Enterprise

• DEFINITION OF CLINICAL RESEARCH

(Clinical Research: A National Call to Action, November 1999) Clinical research is a component of medical and health research intended to produce knowledge valuable for understanding human disease, preventing and treating illness, and promoting health. Clinical Research embraces a continuum of studies involving interactions with patients, diagnostic clinical materials or data, or populations in any of the following categories: (1) disease mechanisms (etiopathogenesis); (2) bi-directional integrative (translational) research; (3) clinical knowledge, detection, diagnosis and natural history of disease; (4) therapeutic interventions including development and clinical trials of drugs, biologics, devices, and instruments; (5) prevention (primary and secondary) and health promotion; (6) behavioral research; (7) health services research, including outcomes, and cost-effectiveness; (8) epidemiology; and (9) community-based and managed care-based trials.

• MAJOR COMPONENTS OF THE CLINICAL RESEARCH ENTERPRISE

Sponsors include private and public sector funding organizations such as the National Institutes of Health, pharmaceutical companies, medical device manufacturers, biotechnology firms, universities, private foundations, and national societies. Within the public sector the National Institutes of Health (NIH) is the largest clinical research sponsor, followed by the Department of Defense (DOD), the Department of Veterans Affairs (VA), Agency for Healthcare Research and Quality (AHRQ), and the Centers for Disease Control (CDC).

Research Organizations

Research organizations include academic health centers, private research institutes, survey research organizations, federal government intramural research programs, and contract research organizations.

Investigators

Investigators are the scientists performing clinical research from varied disciplines with a range of academic qualifications (e.g., MD, Ph.D., RN, DDS, PharmD).

Participants

Participants are the human volunteers, medical information and biological materials of human origin, or data derived from volunteers. Participants may have particular health conditions or may be healthy volunteers or populations at large.

Oversight Entities

Oversight entities include Institutional Review Boards, Food and Drug Administration, Department of Health and Human Services, Veterans Affairs, National Committee for Quality Assurance, and other national regulatory agencies.

Stakeholders/Consumers

Stakeholders/Consumers include health insurers, managed care organizations, health care systems, organized medicine, voluntary health agencies, patient advocacy groups, purchasers of health care, and providers of health care, public health systems, and individual consumers.

• Cite this Page Institute of Medicine (US) Clinical Research Roundtable; Tunis S, Korn A, Ommaya A, editors. The Role of Purchasers and Payers in the Clinical Research Enterprise: Workshop Summary. Washington (DC): National Academies Press (US); 2002. Appendix V, Definitions of Clinical Research and Components of the Enterprise.
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For Referring Physicians

Clinical research: a quick overview, how does clinical research work.

Clinical research is medical research that involves people. Individuals volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose and understand human disease. Read More >>

Who Participates in Clinical Research

A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition. Research procedures with a patient volunteer help develop new knowledge. These procedures may or may not benefit the study participants. Read More >>

What Do I Need to Know If I Am Thinking of Participating?

Learn as much as possible about the clinical trial you are considering. Ask members of the research team questions about the study. Here are some of the questions you might want answered. Read More >>

What Happens After a Clinical Trial is Complete?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about further testing. Read More >>

Ethics in Clinical Research

The goal of clinical research is to develop generalizable knowledge that improves human health or increases understanding of human biology. People who participate in clinical research make it possible to secure that knowledge. Read More >>

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