Summary
The contract provides Clinical Trials Monitoring Services (CTMS) to assist the National Cancer Institute (NCI) in meeting FDA and DHHS regulatory responsibilities for NCI-sponsored clinical trials.
CLINICAL TRIALS MONITORING SERVICE_ Moonshot support
US · IL
National Cancer Institute (NCI), National Institutes of Health (NIH)
grant
open
#nih-75N91022C00013-P00007-9999-2
What they want
The contractor will provide data management, quality assurance, clinical trial monitoring, and auditing capabilities for NCI-sponsored clinical trials conducted by the NCI's Experimental Therapeutics Clinical Trials Network (ETCTN) at domestic and international sites. Additionally, the contract includes auditing biopharmaceutical manufacturing facilities for current Good Manufacturing Practices (GMP) and laboratories for Good Laboratory Practices (GLP).
Deliverables
- Data management for clinical trials
- Quality assurance for clinical trials
- Clinical trial monitoring
- Auditing of NCI-sponsored clinical trials
- Auditing of biopharmaceutical manufacturing facilities for GMP compliance
- Auditing of laboratories for GLP compliance
Technical requirements
- Compliance with Food and Drug Administration (FDA) regulations
- Compliance with Department of Health and Human Services (DHHS) regulations
- Ensuring compliance with current Good Manufacturing Practices (GMP)
- Ensuring compliance with Good Laboratory Practices (GLP)
Market context
inferred from NAICSR&D in Physical, Engineering, Life Sciences (except Nanotech & Biotech)
NAICS 541715
- US market size
- $95B
- Typical award
- $100K – $50M+
Typical buyers
DoDNSFNIHNASADOE
Commonly required
DCAA-compliant accountingITARCMMC L2
