COVID-19: Clinical Research Products Management Center (CRPMC)

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NIAID 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. 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. This project will support study product management and distribution of the study products for COVID-19 clinical trial A5401 (ACTIV-2 Outpatient Monoclonal Antibodies And Other Therapies).