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Clinical Trial Management and Execution

Active

Federal

Response Deadline01/22/2027, 10:00:00 PM UTC

Contract Overview

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

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The Clinical Trial Management and Execution subcontract, issued by the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services, focuses on the operational and clinical execution of human subject research for FDA regulatory science projects. The selected provider will be responsible for managing patient recruitment, trial monitoring, and data collection across various clinical sites, ensuring all activities strictly adhere to Good Clinical Practice guidelines and Institutional Review Board approvals. Key deliverables for this engagement include the submission of clinical study reports, comprehensive patient data sets, and detailed trial outcome summaries. Interested parties should note that the response deadline for this opportunity is January 22, 2027, and the work falls under NAICS code 541714.

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of FDABAA-27-00123.

The full solicitation package (4 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

FY27 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

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Timeline

PostedOct 30

subcontract

Response DeadlineJan 22

Submission deadline

Response Deadline

01/22/2027, 10:00:00 PM UTCin 3 months

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs operational and clinical aspects of human subject research for prime contractors on FDA regulatory science projects. Manages patient recruitment, trial monitoring, and data collection across clinical sites. Requires strict compliance with Good Clinical Practice (GCP) and Institutional Review Board (IRB) approvals. Delivers clinical study reports, patient data sets, and trial outcome summaries.

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