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Clinical Trial Execution and Management

Active

Grant

Response Deadline09/26/2029, 04:00:00 AM 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 Trial Execution and Management supports prime contractors on NIH Collaborative Program Grant projects under the Department of Health and Human Services. The scope of work involves the operational execution of clinical trials, specifically focusing on managing participant enrollment, conducting follow-up assessments, and utilizing clinical facilities and Electronic Medical Records to maintain strict study timelines. The contractor is responsible for delivering enrolled patient cohorts, comprehensive clinical data sets, and trial performance reports. Strict adherence to regulatory standards is required, including compliance with 45 CFR Part 46, obtaining necessary IRB approvals, and ensuring proper registration with ClinicalTrials.gov. The project falls under NAICS code 541714 and has a response deadline of September 26, 2029.

General Info

Subcontract for NIH clinical trial execution, participant management, and regulatory compliance by 2029.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Not specified

Set-Aside

NONE

Documents

This scope was carved out of PAR-27-003.

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

View the prime solicitation

Collaborative Program Grant for Interdisciplinary Teams (RM1 Clinical Trial Optional)

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Timeline

PostedOct 14

subcontract

Response DeadlineSep 26

Submission deadline

Response Deadline

09/26/2029, 04:00:00 AM UTCin almost 3 years

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health

ContactsNo contacts available

OfficeN/A

Organization / Agency

Department Of Health And Human Services → National Institutes Of Health

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs operational execution of clinical trials for prime contractors on NIH Collaborative Program Grant projects. Manages participant enrollment, conducts follow-up assessments, and maintains study timelines using clinical facilities and Electronic Medical Records (EMR). Requires 45 CFR Part 46 compliance, IRB approval, and ClinicalTrials.gov registration. Delivers enrolled patient cohorts, clinical data sets, and trial performance reports.

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