Clinical 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 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.

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."

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.

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