Clinical Research Products Management Center (CRPMC)
- Institution
- FISHER BIOSERVICES, INC., MD
- Principal investigator
- Carina Remgsamai-Nhe
- Funding
- $8.6M
- Duration
- 2025–2026
Moonbase score
Still being scored
Abstract
NIAID Division of AIDS (DAIDS) has a requirement for the management and operation of a Clinical Research Products Management Center (CRPMC) to support NIAID-sponsored clinical research trials both domestically and internationally, with a core focus of HIV/AIDS and its co-morbidities. This contract will provide pharmaceutical services and study product management by providing a cGMP-compliant facility, receipt, storage, labeling, packaging, repackaging, shipping, acquiring, and disposition of study products. This contract will provide cognitive pharmaceutical services including evaluating draft protocols; reviewing site pharmacy monitoring reports and maintaining a site audit pharmacy report database; providing study product storage and stability information, guidance in research pharmacy practice and study product management activities to clinical site pharmacists; and conducting Current Good Manufacturing Practice (cGMP) audits of manufacturing facilities.
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