Summary
The National Cancer Institute (NCI) requires a Clinical Trials Monitoring Service (CTMS) contract to provide data management, quality assurance, clinical trial monitoring, and auditing for NCI-sponsored clinical trials conducted by the ETCTN, both domestically and internationally.
What they want
This acquisition is for a Research and Development Support contract to assist the NCI in fulfilling its responsibilities to the FDA and DHHS regulations as an IND sponsor and funding agency. The CTMS contract will 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.
Deliverables
- Data management services for clinical trials
- Quality assurance services for clinical trials
- Clinical trial monitoring services
- Auditing capability for NCI sponsored clinical trials
- Auditing of biopharmaceutical manufacturing facilities for GMP compliance
- Auditing of laboratories for GLP compliance
Technical requirements
- Compliance with current Good Manufacturing Practices (GMP)
- Compliance with Good Laboratory Practices (GLP)
