Pre-Clinical Consulting Services
ID: 75N95025Q00127_SBType: 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)

Set Aside

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

Original Source

https://sam.gov/opp/e9a3901b0f5246868df00f8cdc5bfa5a/view
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide Pre-Clinical Consulting Services. The objective of this procurement is to gather information on the capabilities of potential contractors to support the Clinical Trials Unit (CTU) at the National Institute of Neurological Disorders and Stroke (NINDS), which oversees numerous clinical research programs and requires expertise in IND and IDE preparations. This initiative is crucial for enhancing clinical trial methodologies and improving research outcomes through strategic partnerships and expert guidance. Interested vendors must submit their capability statements electronically by January 17, 2025, to Frederick Weddington at frederick.weddington@nih.gov, ensuring compliance with specified formatting guidelines and confidentiality requirements.

    Point(s) of Contact
    Frederick Weddington
    (301) 594-6835
    frederick.weddington@nih.gov
    Files
    Title
    Posted
    B. Sources Sought Notice - (SB).pdf
    The file is a Sources Sought Notice (Solicitation Number: 75N95025Q00127_SB) issued by the federal government for Pre-Clinical Consulting Services. The notice seeks information on the availability and capabilities of small business sources, including those that are HUBZone, service-disabled, veteran-owned, woman-owned, and small disadvantaged businesses. The primary goal is to assess potential contractors' qualifications and domestic sourcing capabilities related to clinical research and gene therapy. Interested companies are required to submit detailed capability statements addressing each project requirement, including employee count and qualifications, along with their business type and NAICS code compliance. Responses can help determine acquisition methods, including possible set-asides for small businesses. The notice explicitly states it is for information gathering only and does not commit the government to any contract or payment, nor will responses be regarded as proposals. Responses must be submitted electronically by January 17, 2025, and must adhere to specified formatting guidelines. The notice also emphasizes the need for confidentiality regarding proprietary information. This Sources Sought Notice underscores the government's intention to identify qualified vendors for pre-clinical consulting services, promoting opportunities for small businesses in relevant sectors.
    Statement of Work.pdf
    The National Institutes of Health (NIH), through its National Institute of Neurological Disorders and Stroke (NINDS), is seeking consultancy services to support its Clinical Trials Unit (CTU). The CTU plays a pivotal role in overseeing over 120 clinical research programs, ensuring adherence to quality practices from protocol development through to data analysis. The need for external expertise arises due to the complexities involved in IND (Investigational New Drug) and IDE (Investigational Device Exemption) preparations, necessitating input from multiple stakeholders including the pharmaceutical industry, academia, and patient advocacy groups. Services will be provided virtually from the NINDS campus in Bethesda, MD, facilitating seamless collaboration using NINDS IT resources. The designated points of contact for this service order are Dr. Lauren Reoma and Mr. Bradley Alvarez. This initiative illustrates NINDS's commitment to enhancing clinical trial methodologies and improving research outcomes through strategic partnerships and expert guidance.
    Lifecycle
    Title
    Type
    Pre-Clinical Consulting Services
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