In the
life sciences, a contract research organization (CRO) is a company that provides support to the
pharmaceutical
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field an ...
,
biotechnology
Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used ...
, and
medical device
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
industries in the form of research services
outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development,
biological assay
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a ...
development, commercialization,
clinical development
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for reg ...
,
clinical trials management,
pharmacovigilance
Term Given By Tushar Sharma (UPES Batch 2025)
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmaceutical science relating to the "collection, detection, assessment, monitoring, and prevention" of adverse effects with pharma ...
,
outcomes research Outcomes research is a branch of public health research which studies the end results ( outcomes) of the structure and processes of the health care system on the health and well-being of patients and populations. According to one medical outcomes a ...
, and
Real world evidence.
CROs are designed to reduce costs for companies developing new medicines and drugs in
niche markets. They aim to simplify
entry into drug markets, and simplify development, as the need for large pharmaceutical companies to do everything ‘in house’ is now redundant. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the
NIH
The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
,
EMA, etc.).
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. However, the
sponsor of the trial retains responsibility for the quality of the CRO's work.
CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize in clinical-trials services can offer their clients the expertise of moving a new drug or device from its conception to
FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
/
EMA marketing approval, without the drug sponsor having to maintain a staff for these services.
Organizations who have had success in working with a particular CRO in a particular context (e.g. therapeutic area) might be tempted or encouraged to expand their engagement with that CRO into other, unrelated areas; however, caution is required as CROs are always seeking to expand their experience and success in one area cannot reliably predict success in unrelated areas that might be new to the organization.
Definition, regulatory aspects
The
, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, diet ...
s services as:
[ E6(R2) Good Clinical Practice]
International Council on Harmonisation good clinical practice, 66 ppp, amended Nov 2016, accessed 30 Jan 2018 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."
It further details the sponsor's responsibilities in its
good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...
guidelines:
[
*(5.2.1) A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control.
*(5.2.2) Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf, including trial-related duties and functions that are subcontracted to another party by the sponsor's contracted CRO(s).
*(5.2.3) Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
*(5.2.4) All references to a sponsor in this guideline also apply to a CRO to the extent that a CRO has assumed the trial-related duties and functions of a sponsor.
Guidance from the ]US FDA
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
published in 2013 also speaks to the responsibility of the sponsor to oversee work of the CRO, including the circumstance where risk-based monitoring has been delegated to the CRO.
Market size and growth
, there were over 1,100 CROs in the world, despite continued trends toward consolidation. Many CROs have been acquired while others have gone out of business. The industry is fragmented, with the top 10 companies controlling 56% of the market in 2008[The Top 10 Contract Research Organizations -Positioning, performance and SWOT analyses]
bioportfolio.com, 5 February 2010 and 55% in 2009.
Top CROs by annual revenue
, there was a 15.5% increase in R&D spending from 2015 to 2020. The list of contract research organizations includes the following notable companies worldwide:
#Labcorp
Laboratory Corporation of America Holdings, more commonly known as Labcorp, is an American healthcare company headquartered in Burlington, North Carolina. It operates one of the largest clinical laboratory networks in the world, with a United St ...
($14.00B revenue in 2020)
#IQVIA
IQVIA, formerly Quintiles and IMS Health, Inc., is an American multinational company serving the combined industries of health information technology and clinical research. IQVIA is a provider of biopharmaceutical development and commercial outs ...
($11.35B revenue in 2020)
# PPD, Inc. ($4.68B revenue in 2020)
#Syneos Health
Syneos Health (formerly InVentiv Health Incorporated and INC Research) is a NASDAQ listed American multinational contract research organization based in Morrisville, North Carolina
Morrisville is a town located primarily in Wake County, North Ca ...
($4.41B revenue in 2020)
#ICON PLC
ICON (Public Limited Company) is a NASDAQ listed multinational clinical research organisation that provides consulting, clinical development and commercialization services for the pharmaceutical industry. Irish-headquartered healthcare intellig ...
($2.79B revenue in 2020)
# Parexel ($2.44B revenue in 2017)
# Charles River Laboratories ($2.92B revenue in 2020)
#Wuxi Apptec
WuXi AppTec (WuXi pronounced ''Wu-shee'') is a global pharmaceutical, biopharmaceutical, and medical device company.
The company covers the development cycle through five core operations, including small molecule R&D and manufacturing, biologics ...
($1.01B revenue in 2017)
#Medpace
Medpace Holdings, Inc. (alt. MedPace) is a midsize, clinical contract research organization (CRO) based in Cincinnati, Ohio. It provides services for Phase I-IV of drug and medical device development services including regulatory services and cen ...
($0.92B revenue in 2020)
See also
*List of pharmaceutical companies
This listing is limited to those independent companies and subsidiaries notable enough to have their own articles in Wikipedia. Both going concerns and defunct firms are included, as well as firms that were part of the pharmaceutical industry ...
*Contract manufacturing organization
A contract manufacturing organization (CMO), more recently referred to (and more commonly used now) as a contract development and manufacturing organization (CDMO) to avoid the acronym confusion of Chief Medical Officer or Clinical Monitoring Organ ...
* Research organization
References
{{DEFAULTSORT:Contract Research Organization
Contract research organizations In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...
Biotechnology
Clinical research
Pharmaceutical industry
Pharmaceuticals policy