A--Clinical Research Operations and Management (CROMS)
ID: 75N92025R00010Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NHLBIBETHESDA, MD, 20892, USA

NAICS

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

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/6ff3d7b5249a43ddb2e6dd95c85ff1ed/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is soliciting proposals for the Clinical Research Operations and Management Services (CROMS) contract. This procurement aims to enhance the oversight and efficiency of clinical studies by providing essential systems, tools, and expert resources for data management, site monitoring, and regulatory compliance. The contract is crucial for ensuring high-quality research while adhering to strict federal regulations regarding human subjects, data privacy, and security protocols. The performance period is set from September 30, 2025, to September 29, 2026, with options extending through 2030. Interested parties can reach out to Natalie Bruning at natalie.bruning@nih.gov or Tara C. Knox at knoxt@nhlbi.nih.gov for further details.

    Point(s) of Contact
    Bruning, Natalie
    (301) 827-7528
    natalie.bruning@nih.gov
    Knox, Tara C.
    (301) 827-7551
    knoxt@nhlbi.nih.gov
    Files
    Title
    Posted
    Sol_75N92025R00010 w_attachments.pdf
    The document outlines a Request for Proposal (RFP) from the National Institute of Dental and Craniofacial Research (NIDCR) to provide clinical research management and operational support. The contract aims to enhance oversight and efficiency of clinical studies by supplying NIDCR with essential systems, tools, and expert resources for data management, site monitoring, and regulatory compliance. The solicitation specifies that the performance period is from September 30, 2025, to September 29, 2026, with options extending through 2030. Pricing for the contract, including a fixed fee structure, remains to be negotiated. The document emphasizes strict requirements for compliance with federal regulations, particularly regarding human subjects, data privacy, and security protocols. Key provisions include reporting mandates, potential indirect costs, and conditions for contractor personnel background checks. It also establishes guidelines for invoice submission. The emphasis on contractors adhering to federal standards and policies is significant, highlighting the necessity for transparency and adherence to security practices. Overall, this RFP reflects the government’s commitment to fostering high-quality research while emphasizing regulatory compliance and operational integrity.
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    A--Clinical Research Operations and Management (CROMS)
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