SAM #36C24626Q0851

Sole Source Clinical Trial Medication Manufacturing and Testing for Durham VA Medical Center

This opportunity is a sole source contract for clinical trial support at the Durham VA Medical Center. - Agency: Department of Veterans Affairs, Network Contracting Office 6 (NCO 6), Durham VAMC - Sole source vendor: Campbell University - Purpose: Over-encapsulation and analytic testing of study medication and placebo - Supports a double-blind, placebo-controlled clinical trial evaluating pregnenolone for lower back pain in Iraq/Afghanistan-era Veterans - Scope includes: - Manufacturing study medication and matching placebo - Over-encapsulation process - Analytic testing for quality and consistency - Delivery to Durham VA Health Care System - NAICS code: 541715 (Research and Development in the Physical, Engineering, and Life Sciences, except Nanotechnology and Biotechnology) - Period of performance: One year, no option periods - No specific part numbers or quantities provided - Commercial opportunity is limited due to sole source designation, but similar vendors may be considered for future requirements

Key business details: - Campbell University is the only vendor mentioned and will handle all manufacturing and testing - The contract is for a unique clinical research requirement involving both product and service elements - No additional competitors or alternative products are listed in the notice

Description

INTENT TO SOLE SOURCE The Department of Veterans Affairs Network Contracting Office (NCO 6), Durham Veterans Affairs Medical Center (VAMC) intends to enter into a sole source procurement with Campbell University, 143 Main St., Buies Creek, North Carolina 27506. NAICS code 541715-Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). The proposed contract action is for over-encapsulation, and analytic testing of the study medication and placebo. This is a double-blind, placebo-controlled clinical research trial to determine the efficacy of pregnenolone (vs placebo) to improve symptoms of lower back pain in Iraq/Afghanistan-era Veterans. The contractor shall manufacture and deliver the study medication and matching placebo to the Durham VA Health Care System. The Government intends to solicit and negotiate with only one source under the authority of FAR 13.501. This Advisory and Assistance contract is intended to be for a period of performance of one year, with no option periods.

This notice of intent is NOT a request for quotation. Interested parties may identify their interest in the requirement and capabilities to Monique Cordero at monique.cordero@va.gov no later than 10:00 AM EST, Aug. 7, 2026. Telephone inquiries will not be accepted. All information shall be furnished at no cost or obligation to the government.

No solicitation will be made available. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the government not to complete this proposed contract based upon responses to the notice is solely within the discretion of the Government.

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