Clinical Research Products Management Center (CRPMC)

The National Institute of Allergy and Infectious Diseases seeks a contractor to establish and operate the Clinical Research Products Management Center (CRPMC), supporting NIAID-sponsored clinical research trials, with proposals due June 5, 2026. This is a cost-reimbursement, level-of-effort contract with no set-aside.

Place of performance is the United States. The contractor shall manage receipt, storage, handling, shipping, and disposition of investigational study products at cGMP-compliant facilities; perform inventory management, clinical supply planning, labeling and repackaging, quality management and compliance with ICH GCP, cGMP, and FDA regulations; provide pharmacy site oversight and monitoring; and maintain trial master files and standard operating procedures. Services support four clinical trial networks (ACTG, HPTN, IMPAACT, and HVTN) operating across 161 international sites and 67 domestic sites in 16 countries including South Africa, Malawi, Vietnam, Kenya, Thailand, Brazil, and Mexico. Study products must reach sites within one to five days; quarterly destruction visits are required at up to 150 clinical research site pharmacies located within 3,000 miles of the central distribution facility.

The contract runs for a base period of one year (March 16, 2027 through March 15, 2028) plus six one-year options, totaling seven years. The contractor must provide 27 full-time equivalents during the base year and subsequent option years, with potential increases through Options 7–48 providing additional FTEs to accommodate work volume increases. The anticipated scope includes 20,000 annual shipments (45% international, 55% domestic), repackaging of 78,000 study product units annually, secondary labeling of 250,000 units annually across 350 products, and 65 new protocols per year as planning averages. The COSMOS inventory system will transfer to the awardee with 90-day transition support and training. One award is anticipated, with an award date of March 16, 2027. Offerors must acknowledge receipt of Amendment No. 2 (issued May 15, 2026) and Amendment No. 1 (issued May 7, 2026) on each proposal copy. The NAICS code is 541715. Primary contact is Shawnice Williams, Contracting Officer, at Shawnice.Williams@nih.gov, 301-761-5431.