A--Contract Research Organization for the National In
Key Dates
Due Date
-
Posted Date
-
Agency & Value
Agency
NATIONAL INSTITUTES OF HEALTH NICHD
Contract Value
Not provided
Codes & Classification
Solicitation Number
75N94025R00008
NAICS
541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
Classification Code
AN12
Additional Details
The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions and Logistics Management, acting on behalf of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), has issued a solicitation for a Contract Research Organization (CRO) to support the NIAAA Medications Development Clinical Trials Network. This procurement, identified as 75N94025R00008, is a re-competition for a follow-on contract to continue the clinical trial coordination and support services currently provided under contract 75N94019D00001, previously awarded to Fast-Track Drugs & Biologics, LLC.
The primary purpose of this acquisition is to secure comprehensive CRO services for the development, coordination, and operation of multiple, multi-center pharmacotherapy clinical trials targeting the treatment of Alcohol Use Disorder (AUD). The scope encompasses all aspects of clinical trial support, including but not limited to: clinical trial coordination, clinical site oversight and management, preparation of study documents, electronic data capture from participating sites, Good Clinical Practice (GCP) monitoring, acquisition and facilitation of study medication (including packaging, shipping, and coordination), logistical and meeting services, regulatory support, statistical and data analysis, and preparation and submission of final clinical study reports and manuscripts.
The anticipated contract will be an Indefinite Delivery/Indefinite Quantity (IDIQ) agreement with a seven-year ordering period commencing November 15, 2026. Individual task orders will be issued on a cost plus fixed fee basis as clinical trial needs arise, with an expectation of four to six CRO Clinical Study Support task orders during the contract period. The clinical research sites for each trial will be established under separate NIAAA contracts, ensuring the CRO’s focus remains on coordination and support.
This solicitation is set aside 100% for Small Business concerns, in accordance with the Small Business Administration (SBA) requirements. Eligible offerors must meet the size standard for NAICS code 541715 (Research and Development in the Physical, Engineering, and Life Sciences, except Nanotechnology and Biotechnology), which is 1,000 employees. The procurement also enforces limitations on subcontracting, requiring that the small business prime contractor not pay more than 50 percent of the contract value to subcontractors that are not similarly situated entities.
Offerors are advised that the solicitation and all amendments will be available exclusively through the SAM.gov Contract Opportunities website. Proposals must be submitted electronically via the NIH eCPS website (https://ecps.nih.gov); submissions by facsimile or email will not be accepted. Detailed instructions for proposal submission are provided in the solicitation attachments and Section J of the Request for Proposals.
The procurement is managed by the NIH NICHD office, a federal entity within the Department of Health and Human Services. The primary point of contact for this opportunity is Jason S. Williams, who can be reached at [email protected] or +1 301 443 3877.
Contractors considering this opportunity should note the requirement for robust clinical trial coordination capabilities, adherence to GCP standards, and experience in supporting multi-center pharmacotherapy trials. The contract’s scope and deliverables are designed to ensure rigorous, transparent, and reproducible research outcomes in the field of alcohol use disorder treatment. The solicitation remains active, with proposals due by June 10, 2026.
For further details, including amendments and attachments, interested parties should refer to the official notice at https://sam.gov/opp/a26034f5279d4e0dbf8be83a1fe4a85f/view.
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