Clinical Research Operations Core

Closed Pre-Solicitation Posted

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Solicitation number
75N93025R00019
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Rockville, Maryland, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The National Institute of Allergy and Infectious Diseases (NIAID), part of the Department of Health and Human Services, is seeking a small business contractor to provide Clinical Research Operations Core services through a Sources Sought notice. The agency requires comprehensive support for Phase 0-4 clinical trials focusing on infectious diseases, including emerging and re-emerging pathogens such as SARS-CoV-2, Ebola, and influenza. The contractor will be responsible for managing domestic and international clinical trials, supporting protocol development, clinical operations, and research laboratory analysis activities. Interested small businesses must demonstrate expertise in clinical trial design, execution, project management, and regulatory compliance across seven specific technical areas including clinical trial experience, regulatory compliance, and stakeholder engagement. The submission deadline for tailored Capability Statements is July 2, 2025, at 3:00 PM Eastern Time, with responses limited to five pages and requiring coverage of all specified task areas.

This opportunity does not include any set-aside designations beyond the small business requirement, and no incumbent contractors are identified in the notice. The anticipated contract structure is an Indefinite Delivery Indefinite Quantity (IDIQ) arrangement with a 10-year performance period and 7-year ordering period, with an expected start date of July 2026. The contract anticipates executing a base period task, three task orders in the first contract year, and six task orders in subsequent years, along with two research laboratory analysis task orders annually beginning in year two. While specific budget ranges are not disclosed in this pre-solicitation phase, the extended 10-year performance period and comprehensive scope of clinical research operations support suggests a substantial contract value. The opportunity falls under NAICS code 541715 for Research and Development in the Physical, Engineering, and Life Sciences, indicating the technical complexity and specialized nature of the required services.

Notice text

Please see attached Sources Sought notice for description of supplies and services. 

Files

File Type Posted
Sources Sought - 75N93025R00019.pdf PDF

Notice history

Notice Type Posted
Clinical Research Operations Core Latest pre-solicitation Pre-Solicitation
Clinical Research Operations Core Pre-Solicitation
This notice Original Pre-Solicitation

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