Clinical Research Products Management Center (CRPMC)
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH/DHHS, is issuing a Presolicitation for a Clinical Research Products Management Center (CRPMC). This opportunity seeks expertise and pharmaceutical services for investigational study product management, supporting NIAID's clinical trials, particularly those focused on HIV/AIDS. The RFP is anticipated to be available on/about March 27, 2026.
Scope of Work
The contractor will manage and operate the CRPMC, providing investigational study product management expertise and pharmaceutical services. This includes:
- Receipt, storage, handling, shipping, and disposition of study products.
- Ensuring compliance with cGMP, ICH/GCP, FDA regulations (21 CFR Part 312), and Human Subjects Protection (45 CFR Part 46).
- Supporting NIAID-sponsored clinical research trials, with a core focus on HIV/AIDS and co-morbidities.
Contract & Timeline
- Type: Cost Reimbursement, Term/Level of Effort (LOE)
- Duration: 1 Base Year + 6 One-Year Options (total 7 years possible)
- Level of Effort: 27 Full-Time Equivalents (FTEs) per year for the base and options 1-6.
- Additional Options: Options for increased LOE (2 FTEs, up to 4 times/year; 0.5 FTE, up to 2 times/year) may be exercised.
- Set-Aside: None specified.
- RFP Availability: On/about March 27, 2026, via SAM.gov.
- Period of Performance Start: Approximately March 16, 2027.
Submission Details
- Submission Method: Proposals must be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website (https://ecps.nih.gov). Facsimile or e-mail submissions are not acceptable.
- Consideration: Any responsible offeror may submit a proposal for consideration.
Additional Notes
This is a continuation of a contract initially awarded in 1988, currently held by Fisher BioServices, Inc. The requirement is mission-critical for ensuring the integrity of study products in human clinical trials.