Talk:Contract research organization

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There are non-medical CROs, too; they just aren't as common. I don't know enough about the market to add this formally to the article.

[edit] Merger from Contract Research Organization

This is the text from Contract Research Organization, which can be merged with this article.Marasmusine 11:31, 29 August 2006 (UTC)

A Contract Research Organization (CRO) is an organization that offers clients a wide range of pharmaceutical research services. In the Code of Federal Regulations (CFR), the U.S. Food and Drug Administration regulations state that a CRO is "a person [i.e., a legal person, which may be a corporation] that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration." [21 CFR 312.3(b)]

Services offered by CROs include: product development and formulation, clinical trial management (preclinical through phase IV), central laboratory services for processing trial samples, data management services for preparation of an FDA New Drug Application (NDA) or an Abbreviated New Drug Application (ANDA), and many other complementary services. CROs can offer their clients the experience of moving a new drug from its conception to FDA marketing approval without the drug sponsor having to maintain a staff for these services, which often have limited duration. [1]

I went ahead and put this text in to replace the old introduction paragraph anyway. Marasmusine 11:53, 29 August 2006 (UTC)