A contract research organization, also called a clinical research organization, (CRO) is a service organization that provides support to the pharmaceutical and biotechnology

Biotechnology

Biotechnology is a field of applied biology that involves the use of living organisms and bioprocesses in engineering, technology, medicine and other fields requiring bioproducts. Biotechnology also utilizes these products for manufacturing purpose...

 industries in the form of outsourced

Outsourced

Outsourced is a romantic comedy film, directed by John Jeffcoat, released in 2006.-Plot:When Todd Anderson's job and entire department are outsourced, he reluctantly travels to India to train his replacement...

 pharmaceutical research services (for both drugs and medical devices). 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

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

/EMA

European Medicines Agency

The European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...

 marketing approval without the drug sponsor having to maintain a staff for these services.
The ICH-GCP

ICH-GCP

International Conference on Harmonisation - Good Clinical Practice ICH-GCPClinical studies should be carried out according to International Conference on Harmonisation / WHO Good Clinical Practice standards...

 (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.