SUPPORT FOR CLINICAL AND REGULATORY AFFAIRS PROGRAM

Ogden Bioservices Corporation, Gaithersburg MD

Investigators

Abstract

The objective of this contract is to provide support services for the operations of the Clinical and Regulatory Affairs Branch (CRAB), Division of Microbiology and Infectious Diseases (DMID). The contractor shall be responsible for data collection and compilation; technical report preparation; monitoring of clinical activities: final container packaging; labeling, storage, distribution and tracking of investigational products used under Investigational New Drug Applications (INDs): implementing and maintaining computer information systems: and for providing administrative coordination and general logistical support for the NIAID - Institutional Review Board (IRB) activities, and for the IND - related activities.