Contract research organization

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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 also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMEA, etc.).[1]

Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[2] 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.[3]

Regulatory aspects[edit]

Specifically pertaining to CROs providing clinical-trials services, the International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH-GCP) (E6 1.20) defines a Contract Research Organization (CRO) as: "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.
  • (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.

In spite of this statement of principles, at least one publicly traded biopharmaceutical company that makes use of CROs has stated in investor filings:

Due to our reliance on third party contract research organizations to conduct our clinical trials, we are unable to directly control the timing, conduct, expense and quality of our clinical trials.[4](emphasis added)

Market size and growth[edit]

A significant portion of R&D budgets are spent on outsourcing services (domestic and/or international) offered by the CRO industry, approximately $15 billion in 2007.[5] This figure is expected to grow at 15% over the next seven years and should increase further with the broadening of the spectrum of services outsourced to cover the entire value chain. As outsourced services in developing countries such as China and India move up the value chain to cover phase 1/2 trials, the total contracts value may increase to $20 billion by 2010. Furthermore, certain therapeutic areas within pharmaceutical development are due for an even greater rate of growth, namely the oncology class, expected to see continued growth of upwards of 21% over the next few years[6] due to the large target market, strong unmet medical need, and overwhelming number of drugs currently in development (667 for cancer vs. 252 for CNS disorders, 206 for cadiovascular disorders, and 186 for infections).[7]

An increasing number of clinical trials are run by CROs; the amount spent on CRO-run research increased from $1.6 billion in 1994 to $7.6 billion in 2004. Over the same time period, the share of clinical trials run at academic medical centers dropped from 63% to 26%.[8] As one author put it:

What began as small specialized boutique firms offering narrowly targeted outsourcing services to pharmaceutical clients have come to dominate drug development and clinical trial management.[9]

There are over 1,100 CROs in the world, despite continued trends toward consolidation (many CROs are being acquired in recent times or others go out of business).[10] It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008[11] and down to 55% in 2009.[12][13] One estimate had the size of the market set to reach $24 billion in 2010[14] and set to grow at a rate of 8.5% through 2015.[15]

The largest CROs, according to Industry Standard Research,[16] are Quintiles, Parexel, Covance, Pharmaceutical Product Development (PPD), Icon, INC Research, inVentiv Health inc, and BTS Research.

According to an article in September 2013, the merger of PRA International and ReSearch Pharmaceutical Services (RPS) made the newly named PRA Health Sciences the fourth-largest CRO.[17]

See also[edit]

References[edit]

  1. ^ "The CRO Market", Association of Clinical Research Organizations.
  2. ^ "The CRO Market", Association of Clinical Research Organizations.
  3. ^ "Bio-Definitions", Biotech Media.
  4. ^ United States Securities & Exchange Commission. "Gilead Sciences, Inc. Form 10-Q". Retrieved 25 December 2012. 
  5. ^ "New Research offers CRO market snapshot", Kirsty Barnes, Outsourcing-Pharma, November 22, 2007.
  6. ^ "Riding the Wave", Pharmaceutical Executive Europe, FOCUS Oncology, September 2007, pp. 3–5.
  7. ^ "Top 10 Areas of Research", Michael D. Christel, R&D Directions, vol. 14, no. 9, October 2008, pg. 20.
  8. ^ Steinbrook, R (May 26, 2005). "Gag clauses in clinical-trial agreements.". The New England Journal of Medicine 352 (21): 2160–2. doi:10.1056/NEJMp048353. PMID 15917381. 
  9. ^ Mirowski, P; Van Horn, R (August 2005). "The contract research organization and the commercialization of scientific research.". Social studies of science 35 (4): 503–48. PMID 16304738. 
  10. ^ "CRO Industry Could See More Consolidation, Experts Say" outsourcing-pharma.com 2013-06-20 Retrieved 2013-09-24
  11. ^ [1]
  12. ^ http://www.globalbusinessinsights.com/content/rbcr0015m.pdf[dead link]
  13. ^ "Quintiles in $3bn investment deal". Outsourcing-pharma.com. 2008-01-02. Retrieved 2010-08-03. 
  14. ^ "CRO market to reach $24bn by 2010". Outsourcing-pharma.com. 2007-07-30. Retrieved 2010-08-03. 
  15. ^ "Reportlinker Adds The CRO Market Outlook: Emerging Markets, Leading Players and Future Trends. | Trends & Events > Trends from". AllBusiness.com. 2009-09-21. Retrieved 2010-08-03. [dead link]
  16. ^ "INC Research tops CRO quality ranking as M&A shapes pharma outsourcing". medcitynews.com. 2012-03-01. Retrieved 2012-11-08. 
  17. ^ "PRA plus RPS equals fourth-largest CRO". pharmatimes.com/. 2013-09-26. Retrieved 2014-06-18.