Notice of intent to issue a Sole Source Award for tuberculosis clinical trial management services

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.