Clinical Research Operations Core
Closed Pre-Solicitation Posted
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- Solicitation number
- 75N93025R00019
- Agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Rockville, Maryland, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institute of Allergy and Infectious Diseases (NIAID), a component of the Department of Health and Human Services, is seeking to procure comprehensive clinical research operations support services through an Indefinite Delivery Indefinite Quantity (IDIQ) contract. The procured services will support clinical research implementation, including project management, protocol development, protocol implementation, clinical operations, and research laboratory analysis, with a specific focus on vaccine and biologic product development for infectious diseases, bioterrorism pathogens, emerging diseases, and antimicrobial-resistant infections. Contractors must operate under a fee-for-service model and may be required to assign intellectual property rights related to materials, processes, and products they develop to NIAID and service providers, while also accepting delays in public release of results to allow for patent review and filing. The contract will be structured across three task areas with NIAID anticipating between one and nine awards depending on the specific task area. The presolicitation notice was posted on January 13, 2026, with the full Request for Proposal expected to be available on or about February 26, 2026, and the proposal submission deadline is February 27, 2026.
This procurement carries no set-aside designations and does not identify any current incumbents or potential contractors. The contract will operate as an IDIQ with a seven-year ordering period for most task areas and a ten-year ordering period for Task Area A (Project Management and Protocol Development), with an anticipated start date of July 16, 2026. The presolicitation notice does not provide specific award values or budget ranges for individual task areas or overall contract value. Contractors may propose proprietary or licensed reagents and processes; however, NIAID reserves the right to reject such alternatives in favor of other materials and processes. Interested parties should prepare to submit proposals electronically through the NIAID electronic Contract Proposal Submission (eCPS) website, with access available through SAM.gov, and anticipate that evaluation will prioritize demonstrated capability in clinical research operations, manufacturing of critical reagents and clinical trial materials, and responsiveness to public health emergencies.
Notice text
The purpose of this pending solicitation is to provide the resources and services needed to implement clinical research in support of NIAID’s mission. This will allow NIAID to respond to public health needs including public health emergencies and produce high quality data supporting regulatory and policy decisions.
These services are intended to support:
- A wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I/II trials), fulfill regulatory requirements, and support Phase I/II clinical studies.
- NIAID priority activities including manufacture and characterization of reagents and products to support government supported clinical trials such as those supported by IDCRC.
- Manufacture of critical reagents and clinical trial material to support the wider scientific community and non-government sponsored projects.
NIAID has implemented a Determination of Exceptional Circumstances in accordance with 37 C.F.R. § 401.3(e) (see Advanced Understandings) for NIAID’s preclinical service contracts that include Vaccine (and Other Biologic) Manufacturing Services for Infectious Diseases. Consequently, all contractors are required to operate under a fee-for-service model, and the contractor may be required to assign any intellectual property they file on third part material of information (“Provider Materials”), or new processes, and products relating to Provider Materials they develop and manufacture. The contractor will also be required to delay any public release of results until NIAID and Provider have a chance to review and file patents of their own. The contractors may propose the use of reagents and processes that are proprietary or under license. However, NIAID and the Provider reserve the right to reject the use of these alternative materials and processes.
Files
| File | Type | Posted |
|---|---|---|
| Presolicitation Notice.docx | DOCX document |
Notice history
| Notice | Type | Posted |
|---|---|---|
| Clinical Research Operations Core | Pre-Solicitation | |
| This notice | Pre-Solicitation | |
| Clinical Research Operations Core | Pre-Solicitation |
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