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Data Safety and Monitoring Board (DSMB) Support

Active
Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This small business set-aside subcontract provides essential administrative and technical support to Data Safety and Monitoring Boards for prime contractors conducting NIH/NHGRI clinical trials. The scope of work includes coordinating DSMB meetings, managing the flow of blinded and unblinded data, and preparing critical safety monitoring reports and meeting minutes. Performance will take place in Bethesda, and the contractor must possess specific experience with DSMB charters. Due to the nature of the clinical data involved, a mandatory Business Associate Agreement is required to ensure full HIPAA compliance. Interested parties must submit their responses by November 13, 2026, for this opportunity managed under the Department of Health and Human Services and the National Institutes of Health.

General Info

Small business subcontract for NIH clinical trial DSMB administrative and technical support services.

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Bethesda, MD, USA

Set-Aside

SBA

Documents

This scope was carved out of 75N98026R00034.

The full solicitation package (8 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Clinical Research Support and Collaboration for NHGRI Protocols

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
ContactsNo contacts available
OfficeN/A
Office AddressN/A
ContactsNo contact information available

Full Description

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Provides administrative and technical support to Data Safety and Monitoring Boards (DSMB) for prime contractors on NIH/NHGRI clinical trials. Coordinates DSMB meetings, prepares safety reports, and manages blinded/unblinded data flow. Requires experience with DSMB charters and a mandatory Business Associate Agreement (BAA) for HIPAA compliance. Delivers DSMB meeting minutes and safety monitoring reports.

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W4LD USA Hecsa

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NAICS: 541690
New
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Solicitation # 75N98026R00034
The National Institutes of Health Office of Acquisitions and Logistics Management, on behalf of the National Human Genome Research Institute, is soliciting proposals for an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide comprehensive clinical research support and collaboration services. This small business set-aside acquisition focuses on four primary task areas: protocol monitoring and data management, regulatory support for IND and IDE submissions, Data Safety and Monitoring Board (DSMB) support, and statistical expertise. The contractor must provide qualified personnel experienced in clinical trial design and regulatory requirements, with specific expertise in rare diseases, genetic conditions, gene therapy using AAV9 vectors, and both pediatric and adult populations. The contract features a three-year ordering period beginning January 1, 2027, with performance primarily occurring at the contractor's site and some travel to the NIH campus in Bethesda, Maryland. Award will be made on a competitive best value basis using a tradeoff approach, where non-price factors—including personnel, technical and management approach, offeror experience, and past performance—are significantly more important than cost. Task orders will be issued as either firm fixed-price or time and materials. The contract includes stringent requirements for cybersecurity, the handling of Controlled Unclassified Information, and compliance with Section 508 accessibility standards for all electronic deliverables. Proposals are due by November 13, 2026, and must be submitted via the NIH electronic Contract Proposal Submission website in separate technical and business volumes.
National Institutes Of Health Olao

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