Clinical trial design for HPS pulmonary fibrosis
Closed Pre-Solicitation Posted
- Solicitation number
- 75N98026Q00776
- Agency
-
Office of Logisitics and Acquisition Operations
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541690 Other Scientific and Technical Consulting Services
- PSC
- R412 Support- Professional: Simulation
- Place of performance
- West Lake Hills, Texas 78746, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Office of Logistics and Acquisition Operations is preparing to award a firm-fixed-price purchase order for clinical trial design services in hereditary pulmonary stenosis (HPS) pulmonary fibrosis, with responses due by July 21, 2026 at 11:00 p.m. EDT. The procurement is set aside for total small business, though NIH has announced a sole-source intent to Berry Consultants LLC under contract 75N98026Q00776 per FAR 6.302-1.
The scope requires development of a clinical trial design suitable for presentation to sponsors and regulatory agencies. Work includes characterizing disease progression using available natural history, observational, and clinical trial data; evaluating candidate endpoints and analysis methods; and recommending a design strategy for future interventional trials. Berry Consultants' prior modeling work on the NIH HPS cohort and possession of preliminary data from previous contracts position them as the sole-source rationale; award is anticipated approximately ten days after notice unless another vendor demonstrates equivalent capability.
NIH reserves the right to compete based on capability statements. Small businesses across all categories—including 8(a), service-disabled veteran-owned, HUBZone, small disadvantaged, veteran-owned, and women-owned small businesses—may submit written capability statements by the deadline to david.shen@nih.gov. NAICS 541690 (Other Scientific and Technical Consulting Services); PSC R412 (Support—Professional: Simulation).
Notice text
Attachment: Notice of Intent
Files
| File | Type | Posted |
|---|---|---|
| Notice of Intent.pdf |
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Clinical Research Support and Collaboration for NHGRI Protocols | Office of Logisitics and Acquisition Operations | Total Small Business |
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