MODIFICATION
A -- NIAID CLINICAL PRODUCTS CENTER (CPC)
- Notice Date
- 10/18/2024 8:07:30 AM
- Notice Type
- Solicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- RFP-NIAID-75N93024R00018
- Response Due
- 1/17/2025 12:00:00 PM
- Archive Date
- 02/01/2025
- Point of Contact
- Deborah Blyveis, Phone: 2406695143, Emily Bannister
- E-Mail Address
-
blyveisd@niaid.nih.gov, emily.bannister@nih.gov
(blyveisd@niaid.nih.gov, emily.bannister@nih.gov)
- Small Business Set-Aside
- SBA Total Small Business Set-Aside (FAR 19.5)
- Description
- The purpose of this contract is to provide support to NIAID OPRM for the pharmacy and pharmaceutical oversight responsibilities of national and international NIAID/DAIT supported clinical trials as well as other NIH funded clinical trials on an as-needed basis, to ensure study product integrity, participant safety, pharmacy and pharmaceutical regulatory compliance. This contract provides NIAID with centralized services for: 1) Study Product (i.e., IP management, procurement, receipt, storage, labeling, packaging/repackaging, blinding (i.e., over-encapsulation); placebo manufacturing, sterile product manufacturing and preparation, blister packaging, distribution to site, inventory management, accountability, disposal, and expiration dates and recall monitoring); 2) IP Regulatory Document Maintenance in the DRMC (Regulatory documents relating to shipment, receipt, disposition, return, destruction, manufacturing (placebo, food product immunotherapy, etc.), over-encapsulation (for blinding purposes), stability/sterility protocols and testing, and labeling and packaging; 3) Co-submissions of Drug Master Files (DMFs) and co-conducting product stability studies; and 4) Clinical samples repository, product sterility/stability and release testing, clinical laboratory testing such as Immunoassays, Molecular Diagnostics, DNA Sequencing, Flow Cytometry, etc.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/c418c9f44b534339939d87e2d6098a32/view)
- Place of Performance
- Address: N/A, AX1
- Country: AX1
- Country: AX1
- Record
- SN07243959-F 20241020/241018230100 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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