Notice of intent to issue a Sole Source Award for tuberculosis clinical trial management services
Closed Pre-Solicitation Posted
- Solicitation number
- 75D30126R73392
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541990 All Other Professional, Scientific, and Technical Services
- Place of performance
- Atlanta, Georgia 30329, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention Division of TB Elimination is seeking tuberculosis clinical trial management services to maintain continuity of an active 10-year research portfolio that was interrupted by a government-wide shutdown. The CDC intends to award a sole source firm fixed price purchase order under FAR 12.102(a) authority, classifying this as a commercial service requiring competitive consideration despite the single-source intent. Key contract requirements include clinical trial data intake, analysis, and monitoring capabilities that comply with FDA regulations and support ongoing patient enrollment across multiple active trials. The evaluation will focus on the vendor's ability to continue existing tracking system operations without service interruption, as switching platforms would be impractical given the current data migration status. Interested parties must submit quotations or responses by the February 5, 2026 deadline to the contract specialist at zvm0@cdc.gov, with all responses received within 15 days of the notice's January 21, 2026 issuance being considered for evaluation.
This procurement carries no set-aside designations and identifies OpenClinica LLC as the current incumbent contractor, having designed and implemented the existing tracking system into which all study data has been migrated. The contract is structured as a 1-year bridge award under NAICS code 541990 (All Other Professional, Scientific, and Technical Services) and PSC code DA10 (IT and Telecom – Business Application/Application Development Software as a Service). No specific award value or budget range is disclosed in the pre-solicitation notice. The government retains sole discretion to either proceed with the sole source award or conduct a competitive procurement based on responses received, with the primary objective of ensuring uninterrupted clinical trial operations and FDA-compliant data management throughout the bridge period.
Notice text
The Centers for Disease Control and Prevention Division of TB Elimination intends to award a sole source firm fixed price purchase order to OpenClinica LLC to provide a 1-year bridge contract for tuberculosis clinical trial management services to ensure the continuation of a 10-year cycle research portfolio that had lapsed due to the government wide shut down. OpenClinica LLC designed the current tracking system and has migrated all study data into their platform making it impractical to change vendors within the time needed to support the ongoing clinical trials with active enrollment of patients ongoing. The clinical trial data intake, analysis, and monitoring are essential for tracking performance of the active clinical trials and required by FDA regulation. This contract action is for commercial services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 12.102(a). 541990 - All Other Professional, Scientific, and Technical Services.
This notice of intent is not a request for competitive quotations; however, all quotations/responses received within 15 days of the issuance of this notice shall be considered by the government. A determination by the government not to complete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the contract specialist at email zvm0@cdc.gov by 02/05/2026.
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