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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.).〔("The CRO Market" ), Association of Clinical Research Organizations.〕 Many CROs specifically provide clinical-study and clinical-trial support for drugs and/or medical devices.〔("The CRO Market" ), Association of Clinical Research Organizations.〕 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.〔("Bio-Definitions" ), Biotech Media.〕 ==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. . 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Contract research organization」の詳細全文を読む スポンサード リンク
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