Pre-Clinical Consulting Services
ID: 75N95025Q00127Type: Sources Sought
Overview

Buyer

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

NAICS

Other Scientific and Technical Consulting Services (541690)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Original Source

https://sam.gov/opp/58ddd24eaae6483f98f46c18b289f860/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified vendors to provide Pre-Clinical Consulting Services as part of a Sources Sought Notice (Solicitation Number: 75N95025Q00127). The objective is to identify capable sources that can support the Clinical Trials Unit (CTU) in areas such as clinical research regulatory compliance and gene therapy, enhancing the CTU's ability to manage over 120 clinical research programs effectively. This consulting expertise is vital for the CTU's role in pre-clinical development, particularly in relation to investigational new drug (IND) and investigational device exemption (IDE) processes. Interested firms must submit a capability statement by January 17, 2025, detailing their qualifications and experience, and can contact Frederick Weddington at frederick.weddington@nih.gov or 301-594-6835 for further information.

    Point(s) of Contact
    Frederick Weddington
    (301) 594-6835
    frederick.weddington@nih.gov
    Files
    Title
    Posted
    B. Sources Sought Notice.pdf
    The government issued a Sources Sought Notice (Solicitation Number: 75N95025Q00127) to gather information on qualified sources capable of providing Pre-Clinical Consulting Services. This notice aims to assess the availability and capability of vendors in compliance with specific requirements related to the Clinical Trials Unit (CTU) and associated stakeholders, particularly in areas including clinical research regulatory and gene-therapy domains. Companies interested in responding must submit a capability statement detailing their qualifications, including workforce size and experience, along with relevant military or government acquisition contracts. Responses should identify the business type, applicable NAICS Code, and size standard, while avoiding proprietary information. There is no obligation for the government to award a contract based on this notice, and responses are due by January 17, 2025. Interested firms must follow specific formatting guidelines for submission and provide comprehensive details to support their qualification claims. The document underscores the government’s effort to enhance its consulting capabilities and resources while ensuring compliance with legal and technical standards.
    Statement of Work.pdf
    The National Institute of Neurological Disorders and Stroke (NINDS) aims to enhance clinical research through its Clinical Trials Unit (CTU). The CTU offers support for over 120 clinical research programs by managing all protocol phases, including development, execution, and data analysis. To maintain high-quality practices, the CTU collaborates with various stakeholders, providing education and training to research teams while promoting innovative clinical trial methodologies. To further its mission, the CTU seeks consultant expertise in areas relevant to investigational new drug (IND) and investigational device exemption (IDE)-enabling pre-clinical development. This expertise is crucial for the CTU's role as a sponsor, engaging with diverse organizations such as the pharmaceutical industry and academic institutions. Services will be conducted virtually at the NINDS Intramural Clinical Neurosciences Program in Bethesda, MD, leveraging NINDS IT resources, with the timing to be determined. The designated contacts for this service are Dr. Lauren Reoma and Mr. Bradley Alvarez. Overall, this RFP emphasizes the need for specialized knowledge to support and advance clinical trials at NINDS.
    Lifecycle
    Title
    Type
    Pre-Clinical Consulting Services
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