The Clinical and Regulatory Affairs Support contract provides regulatory expertise and technical and administrative support for DMID's clinical research programs. The scope of activities includes review, preparation and submission of regulatory documents, reports and other agreements; design and conduct of regulatory educational and training activities; and the provision of specialized expertise and regulatory audits. This contract also supported the management and operation of a Clinical Agents Repository for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID sponsored clinical trials and research programs in the U.S. and abroad.
