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First-in-Human (Phase 1) Clinical Evaluation

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Grant

Contract Overview

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

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This subcontract involves the management and execution of Phase 1 first-in-human clinical trials supporting prime contractors on projects for the National Institutes of Health and the National Institute of Neurological Disorders and Stroke. The scope of work includes implementing dosing strategies, monitoring safety and durability, and assessing clinical endpoints alongside translatable biomarkers. To ensure compliance and quality, the provider must maintain GCP certification, secure IRB approval, and utilize established patient recruitment networks. The primary deliverables for this engagement consist of comprehensive clinical trial data, detailed safety reports, and efficacy results. This effort falls under NAICS code 621910 and is administered through the Department of Health and Human Services. The solicitation was posted on November 3, 2026, with a response deadline set for October 10, 2028.

General Info

Subcontract for Phase 1 clinical trials supporting NIH and NINDS medical research projects.

Agency

Department Of Health And Human Services → National Institutes Of Health

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of RFA-NS-28-012.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)

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Timeline

Posted

subcontract

Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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

Full Description

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Performs management and execution of Phase 1 first-in-human clinical trials for prime contractors on NIH/NINDS projects. Implements dosing strategies, monitors safety and durability, and assesses clinical endpoints and translatable biomarkers. Requires GCP certification, IRB approval, and patient recruitment networks. Delivers clinical trial data, safety reports, and efficacy results.

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