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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, EMA, etc.).

Contents

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.

Regulatory aspects

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.

    • Market size and growth

    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). It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008 and down to 55% in 2009. One estimate had the size of the market set to reach $24 billion in 2010 and set to grow at a rate of 8.5% through 2015.

    However, more recent data reveal a 15.5% increase in R&D spend from 2015 to 2020.

    As of 2016, the top 10 CROs by revenues are considered to be:

    1. Quintiles ($4.3B revenues in 2015)
    2. Covance ($2.5B revenues in 2014 before its acquisition by LabCorp)
    3. Parexel ($2.1B revenues in 2015/16)
    4. inVentiv Health ($2.0B revenues in 2015)
    5. Icon plc ($1.57B revenues in 2015, headquartered in Dublin, Ireland)
    6. PRA Health Sciences ($1.4B revenues in 2015)
    7. Pharmaceutical Product Development ($1.35B revenues in 2014),
    8. Charles River Laboratories ($1.4B revenues in 2015)
    9. Chiltern International Ltd. (approaching $1B revenues)
    10. INC Research (approaching $1B revenues)

    References

    Contract research organization Wikipedia
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