First-in-Human (Phase 1) Clinical Evaluation
Contract Overview
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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
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Not specifiedSet-Aside
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.
Genomic and Biologic Therapies for ADRD (U01 Clinical Trial Optional)
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