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Clinical Research Organization (CRO)

Active

SBIR / STTR

Response Deadline04/06/2027, 04:00:00 AM UTC

Contract Overview

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

AI Contract Overview

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This subcontract opportunity with the Department of Health and Human Services is for a Clinical Research Organization to manage and execute clinical trials for small businesses on NIH STTR projects. The selected provider will be responsible for patient recruitment, trial monitoring, clinical data management, and regulatory submission support, utilizing specialized management software and medical monitoring equipment. All operations must maintain strict FDA compliance and obtain necessary IRB approvals to deliver comprehensive clinical trial reports, patient outcome data, and regulatory filings. The procurement is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 541715. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

General Info

HHS seeks a small business CRO to manage NIH STTR clinical trials.

Agency

Department of Health and Human Services

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

Not specified

Set-Aside

SBA

Documents

This scope was carved out of PA-27-102.

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

View the prime solicitation

NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional)

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Timeline

PostedMay 28

subcontract

Response DeadlineApr 6

Submission deadline

Response Deadline

04/06/2027, 04:00:00 AM UTCin 5 months

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Organization & Contact Information

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AgencyDepartment of Health and Human Services

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment of Health and Human Services

Office AddressN/A

ContactsNo contact information available

Full Description

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Manages and executes clinical trials for small businesses on NIH STTR projects. Performs patient recruitment, trial monitoring, regulatory submission support, and clinical data management. Utilizes clinical trial management software and medical monitoring equipment. Requires IRB approval and FDA compliance. Delivers clinical trial reports, patient outcome data, and regulatory filings.

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