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

NIH RePORTER · NIH · N01 · $1,196,744 · view on reporter.nih.gov ↗

Abstract

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).

Key facts

NIH application ID
10244841
Project number
75N93020C00032-0-9999-2
Recipient
FISHER BIOSERVICES, INC.
Principal Investigator
NEERAJA PUTTA
Activity code
N01
Funding institute
NIH
Fiscal year
2020
Award amount
$1,196,744
Award type
Project period
2020-06-16 → 2021-06-15