A contract research organization (CRO) is a service organization that provides support to the pharmaceutical and biotechnology industries in the form of research services outsourced (often domestically) on a contract basis. A CRO can provide such services as biopharmaceutical development, preclinical research, clinical research, and clinical trials management. Many CROs (but not all CROs) specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.[1] CROs range from large, international full-service organizations to small, niche specialty groups. CROs that specialize 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.[2]
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Specifically pertaining to CROs providing clinical-trials services, the 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."
Furthermore, it states that:
A significant portion of R&D budgets are used for outsourcing services (domestic and/or international) 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. Furthermore, 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 CRO companies in the world. It is a very fragmented industry with the top 10 controlling 56.1% of the market in 2008.[7]