Contract research organization

Contract research organization

A contract research organization, also called a clinical research organization, (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of outsourced pharmaceutical research services (for both drugs and medical devices).[1] CROs range from large, international full service organizations to small, niche specialty groups and can offer their clients the experience 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.[2]

Contents

Regulatory aspects

The ICH-GCP (E6 1.20) definition of a Contract Research Organization (CRO) is: "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions."

Furthermore, it states that:

  • (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.

Market size and growth

A significant portion of R&D budgets are used for the outsourcing services offered by the CRO industry, approximately $15 billion in 2007.[3] 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 go up to $20 billion by 2010. Further, certain therapeutic areas within pharmaceutical development are slated for an even greater growth curve, namely the oncology class, expected to see continued growth of upwards of 21% over the next few years[4] 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).[5][6]

There are over 1,100 companies in the world. It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008.[7]

See also

References

  1. ^ "The CRO Market", Association of Clinical Research Organizations.
  2. ^ "Bio-Definitions", Biotech Media.
  3. ^ "New Research offers CRO market snapshot", Kirsty Barnes, Outsourcing-Pharma, November 22, 2007.
  4. ^ "Riding the Wave", Pharmaceutical Executive Europe, FOCUS Oncology, September 2007, pp. 3–5.
  5. ^ "Top 10 Areas of Research", Michael D. Christel, R&D Directions, vol. 14, no. 9, October 2008, pg. 20.
  6. ^ Celticor Clinical Research and Site Management Coimbatore www.celticor.com
  7. ^ http://www.bioportfolio.com/cgi-bin/acatalog/The-Top-10-Contract-Research-Organizations-Positioning_-performance-and-SWOT-analyses.html

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