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Clinical Validation and FDA Regulatory Affairs

Active

Federal

Response Deadline10/13/2026, 04:00:00 PM UTC

Contract Overview

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

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This subcontract for Clinical Validation and FDA Regulatory Affairs supports prime contractors on ARPA-H REST projects within the Department of Health and Human Services. The scope of work involves the design and management of pilot and pivotal FDA trials, including patient recruitment and the analysis of clinical data to ensure specific AUC and sensitivity metrics are met. The selected provider must adhere to Good Clinical Practice and FDA regulatory submission standards to deliver comprehensive clinical trial reports, validated performance data, and FDA submission dossiers. The opportunity was posted on September 14, 2026, with a response deadline of October 13, 2026, under NAICS code 541611.

General Info

Subcontract for ARPA-H clinical validation and FDA regulatory affairs for REST projects.

Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)View Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

DC

Set-Aside

NONE

Documents

This scope was carved out of ARPA-H-SOL-26-159.

The full solicitation package (10 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Restorative and health-Enhancing Sleep Time (REST)

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Timeline

PostedSep 14

subcontract

Response DeadlineOct 13

Submission deadline

Response Deadline

10/13/2026, 04:00:00 PM UTCin 29 days

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → Advanced Research Projects Agency For Health (arpa-H)

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Office AddressN/A

ContactsNo contact information available

Full Description

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Performs clinical trial management and regulatory filings for prime contractors on ARPA-H REST projects. Designs and manages pilot and pivotal FDA trials, handles patient recruitment, and analyzes clinical data to meet AUC and sensitivity metrics. Requires adherence to Good Clinical Practice (GCP) and FDA regulatory submission standards. Delivers clinical trial reports, FDA submission dossiers, and validated performance data.

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