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Protocol Monitoring and Data Management Support

Active
Federal

Contract Overview

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

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This subcontract opportunity, titled Protocol Monitoring and Data Management Support, involves providing clinical trial protocol monitoring and research data management for prime contractors on NIH/NHGRI clinical research projects. The scope of work includes monitoring clinical research protocols, managing data services, and developing transition and startup documentation to deliver validated research datasets and monitored protocol reports. Performance will take place in Bethesda, and the project is categorized under NAICS code 541715. The contract is designated as a Total Small Business Set Aside for the National Institutes of Health under the Department of Health and Human Services. To ensure regulatory compliance, the selected provider must adhere to NIH ICO Information Security and Privacy certifications and execute a Business Associate Agreement for HIPAA compliance. Responses are due by November 13, 2026.

General Info

Clinical trial monitoring and data management for NIH/NHGRI projects. Due November 13, 2026.

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

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

Place of Performance

Bethesda, MD, USA

Set-Aside

SBA

Documents

This scope was carved out of 75N98026R00034.

The full solicitation package (8 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Clinical Research Support and Collaboration for NHGRI Protocols

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
ContactsNo contacts available
OfficeN/A
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao
Office AddressN/A
ContactsNo contact information available

Full Description

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Performs clinical trial protocol monitoring and research data management for prime contractors on NIH/NHGRI clinical research projects. Monitors clinical research protocols, manages data services, and creates transition/startup documentation. Requires compliance with NIH ICO Information Security & Privacy certifications and execution of a Business Associate Agreement (BAA) for HIPAA compliance. Delivers monitored protocol reports and validated research datasets.

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