The general objective of the contract is to provide research support services for the operations of the CRAB, DMID, NIAID by being responsible for the data collection and compilation, technical report preparation, monitoring of clinical activities -- if requested by Project Officer, administrative coordination, and general logistical support particularly in the area of investigational drugs and vaccines subject to FDA regulations. Currently the DMID sponsors about 50 INDs or Master Files and about 120 clinical trials. The contractor will support the on-going and future activities of the CRAB, DMID by: obtaining the necessary information to file and to update INDs, especially by preparing the annual report for each IND; by developing and implementing information systems that facilitate the provision of the clinical and regulatory support services, monitoring the progress of the clinical trials, and providing general administrative and logistical support to the CRAB, DMID.
