Contract research organization
A contract research organization (CRO) is an organization 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 provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs provide a more affordable outlet for companies to pursue new medicines, and a cost-effective solution to develop drugs for even niche markets. Working with CROs, entry into drug development has become immensely simplified, as the need for large pharma 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, EMA, etc.).
Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices. 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/EMA marketing approval, without the drug sponsor having to maintain a staff for these services.
Definition, regulatory aspects
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as::10 "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."
- (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.
Market size and growth
As of 2013[update], 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.[dead link] The industry is fragmented, with the top 10 companies controlling 56% of the market in 2008 and 55% in 2009. One estimate from 2007 had the size of the market set to reach $24 billion in 2010 and another estimate from 2009 set to grow at a rate of 8.5% through 2015.
- IQVIA ($4.3B revenues in 2015)
- Covance ($2.5B revenues in 2014, before its acquisition by LabCorp)
- PAREXEL ($2.1B revenues in 2015/16)
- inVentiv Health ($2.0B revenues in 2015)
- ICON plc ($1.57B revenues in 2015, headquartered in Dublin, Ireland)
- PRA Health Sciences ($1.4B revenues in 2015)
- Pharmaceutical Product Development ($1.35B revenues in 2014),
- Charles River Laboratories ($1.4B revenues in 2015)
- Chiltern International Ltd. (approaching $1B revenues)
- INC Research (approaching $1B revenues)
- Clintract, Inc. ($830 million in revenue)
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- "Bio-Definitions", Biotech Media.[dead link]
- E6(R2) Good Clinical Practice International Council on Harmonisation good clinical practice, 66 ppp, amended Nov 2016, accessed 30 Jan 2018
- "CRO Industry Could See More Consolidation, Experts Say" outsourcing-pharma.com, 2013-06-20 Retrieved 2013-09-24
- The Top 10 Contract Research Organizations -Positioning, performance and SWOT analyses bioportfolio.com, 5 February 2010
- "The CRO Market Outlook!publisher =globalbusinessinsights.com" (PDF). Archived from the original (PDF) on December 18, 2010. Retrieved February 5, 2013.
- "Quintiles in $3bn investment deal". Outsourcing-pharma.com. 2008-01-02. Retrieved 2010-08-03.
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- Ed Miseta (11 February 2016). "Clinical Outsourcing Market To See Continued Growth Through 2020". www.clinicalleader.com.
- Peter Hogg (2016-07-03). "Top 10 Contract Research Organisations (CROs) to Watch in 2016". ProClinical Life Sciences Recruitment Blog. Retrieved 2016-07-03.