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Data and Safety Monitoring Board (DSMB) Services

Active
Federal

Contract Overview

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

General Info

NAICS

541690 - Other Scientific and Technical Consulting Services

Place of Performance

Bethesda, MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N94027R00002.

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

View the prime solicitation

EmbraceHEALTH Clinical Research Network (EmbraceHEALTH CRN)

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Timeline

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Organization & Contact Information

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

Full Description

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Provides independent safety oversight for prime contractors on NIH/NIMHD clinical trials. Reviews interim safety data, monitors adverse events (AEs) and serious adverse events (SAEs), and provides recommendations to modify or stop trials. Utilizes independent secure data review portals. Requires independent medical/scientific expertise and GCP compliance. Delivers periodic safety monitoring reports and DSMB recommendations.

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Same NAICS industry code

More opportunities from Department Of Health And Human Services → National Institutes Of Health Nichd

Same awarding agency

NAICS: 541715
New
Federal
EmbraceHEALTH Clinical Research Network (EmbraceHEALTH CRN)
Solicitation # 75N94027R00002
The National Institute on Minority Health and Health Disparities (NIMHD) within the National Institutes of Health (NIH) has issued a Small Business Sources Sought Notice (75N94027R00002) to identify qualified small businesses capable of establishing and operating Research Consortia within the EmbraceHEALTH Clinical Research Network. The primary objective is to conduct solutions-oriented clinical, behavioral, and health services research aimed at reducing health disparities and improving health outcomes for affected populations across the U.S. and its territories. The anticipated contract vehicle is an Indefinite Delivery, Indefinite Quantity (IDIQ) agreement with an approximate five-year ordering period, where specific research activities will be assigned on a task order basis. Qualified respondents must operate under NAICS code 541715, with a small business size standard of 1,000 employees or less. To be deemed capable, organizations must demonstrate extensive experience in managing clinical and behavioral intervention studies in real-world healthcare settings, specifically those involving populations experiencing health disparities. Required capabilities include expertise in biostatistics, implementation science, data science, and informatics, as well as the infrastructure for electronic health record extraction, biospecimen collection, and secure data management. All clinical trials must adhere to FDA regulations and Good Clinical Practice (GCP) requirements. Interested small businesses, including SDB, WOSB, HUBZone, VOSB, and SDVOSB designations, must submit a capability statement by November 19, 2026. This statement must include the company's UEI, physical address, point of contact information, and details regarding any teaming arrangements or commercial availability of services. Submissions should be sent in MS Word or PDF format to Contract Specialist Jordan Neal and Contracting Officer Gannon White. This notice is for market research purposes only and does not constitute a formal solicitation or an obligation for the government to award a contract.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

about 7 hours ago

DEADLINE

in 15 days
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