The contract provides support services for the operations of the Cancer Therapy Evaluation Program, particularly the Investigational Drug Branch, Regulatory Affairs Branch, Biometric Research Branch and the Protocol and Information Office. The contractor is responsible for the data collection/compilation, technical report preparation, monitoring of clinical activities, administrative coordination, and general logistical support, particularly in the area of investigational drugs which are subject to regulation by the Food and Drug Administration (FDA). The contract is divided into two principal parts: A. Clinical Research/FDA compliance support which includes: a) Clinical Research Support b) Regulatory Affairs Support c) Drug Distribution Support B. Protocol and Information Support which includes: a) Protocol Review and Approval b) Protocol Information Tracking and Dissemination c) Protocol Results and Publications
