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Clinical Trial Site/CRO Services

Active

Grant

Response Deadline05/25/2029, 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 Site/CRO Services supports prime contractors on NIH P01 clinical trials by managing participant recruitment, enrollment, and clinical data collection. The scope of work includes overseeing site activation and the implementation of electronic tracking systems, utilizing specialized tools such as CTMS, EDC software, and patient registries. To ensure regulatory compliance, the provider must maintain GCP certification and adhere to 45 CFR Part 46 and ClinicalTrials.gov registration requirements. The project is managed under the National Institutes of Health within the Department of Health and Human Services, falling under NAICS code 541714. A key deliverable of the contract is the provision of standardized activation and enrollment performance data required for the Research Performance Progress Report. The solicitation was posted on October 14, 2026, with a response deadline set for May 25, 2029.

General Info

Subcontract for NIH clinical trial site services managing recruitment, enrollment, and data collection.

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 PA-27-061.

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

View the prime solicitation

NIH Research Program Projects (Parent P01 Clinical Trial Optional)

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Timeline

PostedOct 14

subcontract

Response DeadlineMay 25

Submission deadline

Response Deadline

05/25/2029, 04:00:00 AM UTCin over 2 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 participant recruitment, enrollment, and clinical data collection for prime contractors on NIH P01 clinical trials. Manages site activation and implements electronic tracking systems. Utilizes CTMS, EDC software, and patient registries. Requires GCP certification and adherence to 45 CFR Part 46 and ClinicalTrials.gov registration. Delivers standardized activation and enrollment performance data for the RPPR.

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