CLINICAL TRIALS MONITORING SERVICE

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This is a Research and Development Support contract. The purpose of this acquisition is to assist the NCI in fulfilling its responsibilities to the Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations as IND sponsor and funding agency. The scope of the Clinical Trials Monitoring Service (CTMS) contract is to provide data management, quality assurance, clinical trial monitoring, and auditing capability for NCI sponsored clinical trials conducted by the NCI's Experimental Therapeutics Clinical Trials Network (ETCTN) at participating sites both domestically and internationally. Additionally, the CTMS contract provides a mechanism for the auditing of biopharmaceutical manufacturing facilities to ensure compliance with current Good Manufacturing Practices (GMP) and compliance with Good Laboratory Practices (GLP) for laboratories performing integral assays.