Clinical Research Support and Collaboration for NHGRI Protocols
Open Solicitation Posted
- Solicitation number
- 75N98026R00034
- 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
- R499 Support- Professional: Other
- Place of performance
- Bethesda, Maryland, United States
Notice details come from SAM.gov. Updated .
About this opportunity
NIH's Office of Logistics and Acquisition Operations is soliciting clinical research support and collaboration services on behalf of the National Human Genome Research Institute (NHGRI) under RFQ 75N98026R00034, with questions and Notice of Intent due October 29, 2026 and quotations due November 13, 2026 at 12:00 p.m. Eastern Time. The Set Aside line is Total Small Business, and the RFQ states a $19 million size standard for NAICS 541690.
The vehicle is a single-award IDIQ with a three-year ordering period from January 1, 2027 through December 31, 2029, a $50,000 minimum, and a $4 million maximum. Task orders are priced on a time-and-materials basis across four task areas: protocol monitoring and data management, regulatory support for IND and IDE submissions, DSMB administrative support, and statistical expertise. Work is performed primarily at the contractor's site, with occasional travel to NHGRI facilities in Bethesda, Maryland, and the contractor receives a Government laptop and system access.
Personnel must have clinical trial design and regulatory experience applicable to rare diseases, genetic conditions, gene therapy including AAV9 vectors, and pediatric and adult populations. Attachment 03 states that senior statisticians are preferably Ph.D.s in statistics. Attachment 06 requires background investigations by position risk level (Low Risk/NACI, Moderate Risk/MBI, or High Risk/Background Investigation), NIST SP 800-53 controls, FIPS 140-3 encryption, and incident notification within one hour of discovery. Attachment 02 designates three sample task orders for evaluation only, stating they will not be awarded with the parent contract, while Attachment 01 states Task Order 1 will be awarded with the parent contract. Offerors should confirm this before pricing.
Evaluation is best value through a tradeoff among price and non-price factors. Technical factors are Personnel, Technical and Management Approach, Offeror Experience, and Past Performance, listed in descending order of relative importance per Attachment 03, and each receives a High, Some, or Low Confidence rating, with Low Confidence resulting in exclusion from award.
Proposals must be submitted through eCPS only, with separate searchable PDF files for technical and business proposals. The technical proposal is limited to 25 pages, and pages beyond the limit are removed unreviewed. Proposals may not contain internet URLs. Price is submitted separately, and no more than ten clarification questions are accepted by October 29, 2026.
Notice text
The goal of this acquisition is to acquire a contractor that offers a full range of (1) clinical research services, including clinical research management, statistical design and analysis, protocol development and data management, clinical site management, pharmacovigilance services, quality assurance, and regulatory affairs support; (2) specialty services, including DSMB services; (3) analytical solutions, including bioinformatics, and (4) integrated clinical trial management through an organized system of tracking clinical trials. The contractor should be capable of providing these services, as required under the individual task orders, to support NHGRI clinical research protocols and related activities within the scope of this IDIQ contract. The contractor should be capable assigning qualified personnel with experience in clinical trial design and regulatory requirements, especially as relates to studies of rare diseases, genetic conditions, gene therapy (including via AAV9 vectors), and pediatric as well as adult populations, as applicable to individual task orders.
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| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| Risk Underlying Rural Areas Longitudinal (RURAL) H | Office of Logisitics and Acquisition Operations | No set-aside |
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