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Clinical Trial Design and Management

Active
Federal

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 contract involves the development and management of clinical trial protocols, including support for Investigational New Drug (IND) applications and Risk Evaluation and Mitigation Strategies (REMS) proposals. It also encompasses coordination with clinical sites to ensure regulatory compliance and effective execution of clinical trials. The work falls under the NAICS code 541611, which pertains to administrative management and general management consulting services, indicating a focus on specialized professional services in clinical trial oversight. Issued by the Department of Health and Human Services through the BARDA offices, this subcontract was posted on March 20, 2026, with a response deadline extending to September 25, 2028. While specifics on the place of performance and point of contact are not provided, the contract emphasizes regulatory alignment and operational coordination to support clinical research activities, aimed at facilitating successful trial design and implementation in line with federal health regulations.

General Info

Develop and manage clinical trial protocols, support IND and REMS, ensure regulatory compliance.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

DC, USA

Set-Aside

NONE

Documents

(0)

No documents available

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Timeline

Posted

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Response Deadline

Submission deadline

Response Deadline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
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Office AddressN/A
ContactsNo contact information available

Full Description

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Development of clinical trial protocols, IND support, REMS proposals, and coordination with clinical sites for regulatory compliance and execution.

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