Notice of intent to issue a Sole Source Award for tuberculosis clinical trial management services
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The Centers for Disease Control and Prevention (CDC), Division of TB Elimination, intends to issue a sole source firm fixed-price purchase order to OpenClinica LLC for tuberculosis clinical trial management services. This is a 1-year bridge contract to ensure the continuation of a 10-year research portfolio. Responses from other interested parties are due by February 5, 2026.
Scope of Work
This contract will provide essential services for managing tuberculosis clinical trials, including:
- Clinical trial data intake
- Data analysis
- Monitoring of active clinical trials
These services are crucial for tracking performance of ongoing trials with active patient enrollment and are required by FDA regulation.
Contract & Timeline
- Type: Firm Fixed-Price Purchase Order (Sole Source Intent)
- Duration: 1-year bridge contract
- Set-Aside: None specified (Sole Source)
- Response Due: February 5, 2026, by 4:00 PM ET
- Published: January 20, 2026
- NAICS: 541990 - All Other Professional, Scientific, and Technical Services
- PSC: DA10 - Support Services, Delivered As A Service Contract (Saa S Or Subscription) Involved With The Analysis, Design, Development, Code, Test And Release Packaging Services Associated With Application Development Projects, As Well As Off The Shelf Business Software.
Evaluation
The CDC intends to solicit and negotiate with only one source, OpenClinica LLC, under the authority of FAR 12.102(a). OpenClinica LLC designed the current tracking system and has migrated all study data, making a vendor change impractical given the need to support ongoing clinical trials.
Additional Notes
This notice of intent is not a request for competitive quotations. However, all quotations/responses received within 15 days of issuance will be considered. The government retains discretion on whether to conduct a competitive procurement based on responses. Information received will primarily determine if a competitive procurement is feasible. Responses should be emailed to the contract specialist.