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Agencies 1

World Wide Regulatory Agencies
Amy Lynn Wooldridge
HCA375: Continuous Quality Monitoring & Accreditation
Instructor: Heather Ables
December 4, 2011

Agencies 2 “Clinical Contract Research Organizations (CROs) provide a range of services from consulting to labor- intensive tasks such as data processing”. (Kaluzny & McLaughlin, 2006, p.318) The majority of CRO growth is accounted for by pharmaceutical & biotechnology industries. The contract research organization is contracted by a sponsor or client to perform several functions and duties related to clinical trials. (Kaluzny & McLaughlin, 2006, p. 319) The clinical trials are designed to obtain regulatory approval to market new pharmaceutical or biotechnology products. (Kaluzny & McLaughlin, 2006, p. 319) The services they perform for such clients as pharmaceutical companies include: “consulting and advice related to the design of drug development programs to labor-intensive services that are part of the drug development process; these include clinical monitoring of investigational sites, data management and statistical analysis, and presentations of regulatory submissions for review by regulatory agencies such as the U.S. Food and Drug Administration”. (Kaluzny & McLaughlin, 2006, p. 319) The FDA in the United States clearly mandate practices to protect the public’s health by implementing laws, regulations, and guidelines that provide oversight of the drug development process. (Kaluzny & McLaughlin, 2006, p. 322) The FDA requires the CRO to complete an IND or investigational New Drug application. “The pharmaceutical industry sometimes seeks advice from the FDA prior to submission of an IND”. (The FDA’s Drug Review Process, 2011) Throughout the whole process the FDA participates or more like regulates these clinical trials. The CROs as well as the

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