Regulatory Divisions
Division of Regulated Activities and Compliance (DRAC) is a multidisciplinary team of regulatory affairs and compliance professionals dedicated to support the USAMMDA mission. DRAC provides full service regulatory support for products through the DoD acquisition spectrum, from individual investigator-initiated clinical studies to products in the advanced development pipeline. DRAC carries out its delegated responsibilities as the Office of The Surgeon General Sponsor’s (OTSG) representative for the Army regarding medical materiel development, and its operations are mandated in FDA, DoD, and Army regulatory requirements. DRAC supports investigators at medical centers and laboratories, institutional review boards, and product development teams in laboratories and advanced development organizations throughout the Army and the DoD.
Clinical Service Support Division (CSSD) supports the development of medical products by providing expert assistance in the areas of IND product manufacturing, testing and accountability; clinical study monitoring; clinical data management; biostatistics, including study design and data analysis; and adverse event monitoring and reporting.
Read more about this topic: United States Army Medical Materiel Development Activity
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