Loren Data's SAM Daily™

fbodaily.com
Home Today's SAM Search Archives Numbered Notes CBD Archives Subscribe
SAMDAILY.US - ISSUE OF OCTOBER 20, 2024 SAM #8363
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
 
Record
SN07243959-F 20241020/241018230100 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

FSG Index  |  This Issue's Index  |  Today's SAM Daily Index Page |
ECGrid: EDI VAN Interconnect ECGridOS: EDI Web Services Interconnect API Government Data Publications CBDDisk Subscribers
 Privacy Policy  Jenny in Wanderland!  © 1994-2024, Loren Data Corp.