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
    Currently viewing
    Sources Sought
    Similar Opportunities
    Pre-Clinical Consulting Services
    Health And Human Services, Department Of
    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.
    Biological Therapeutics Product Development Subject Matter Expert Consultants
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Neurological Disorders and Stroke (NINDS), is seeking proposals for consulting services from subject matter expert (SME) consultants to support the development of biological therapeutics. The objective of this procurement is to engage SMEs who can provide technical recommendations across various phases of drug discovery and development, including chemistry, regulatory affairs, and clinical trial design, particularly for novel therapeutics aimed at neurological disorders and rare genetic conditions. This initiative is crucial for advancing NIH drug discovery programs and ensuring that innovative therapeutic solutions progress efficiently to clinical evaluation. Interested vendors must submit their proposals by January 27, 2025, and can direct inquiries to Shayna Simpson at shayna.simpson@nih.gov or Kelly Dempsey at kelly.dempsey@nih.gov. The contract is expected to span one year with two optional extensions, and the anticipated performance period is from April 1, 2025, to March 30, 2026.
    SOURCES SOUGHT: Neurodegenerative Disease Scientific Data Analysis and Consulting Services
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small business sources for scientific data analysis and consulting services related to neurodegenerative diseases, particularly Alzheimer’s disease and related dementias. The objective of this procurement is to obtain advanced analytics support to integrate and analyze complex datasets, including imaging, genomic, and clinical data, to identify disease mechanisms and therapeutic targets. This initiative is crucial for enhancing research capabilities and ensuring data accessibility and interoperability within the scientific community. Interested parties must submit their capability statements by January 24, 2025, to Hashim Dasti at hashim.dasti@nih.gov, with no costs incurred by the government for responses.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for a contract to provide pharmacy and pharmaceutical oversight for clinical trials, both nationally and internationally. The primary objective of this contract is to ensure the integrity of study products, participant safety, and compliance with pharmacy and pharmaceutical regulations throughout various NIH-funded clinical trials. This opportunity is critical for maintaining high standards in public health research, as it encompasses a wide range of services including product management, regulatory document maintenance, and clinical laboratory testing. Proposals are due by January 17, 2025, with the contract expected to commence on April 1, 2026, and run through March 31, 2027, potentially extending through 2033. Interested parties can contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov for further information.
    STRATEGIC CONSULTING AND PLANNING SERVICES
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to engage Colbert Consulting, LLC for strategic consulting and planning services to support the National Institute of Nursing Research (NINR). The contractor will assist in the development and implementation of a strategic plan that addresses significant health challenges, including health equity and community health, through the planning of scientific meetings and the creation of relevant scientific materials. This sole-source contract, valued at $148,800, is set to run from January 20, 2025, to January 19, 2026, and interested parties may submit capability statements to Ms. Van Holley at holleyv@od.nih.gov by January 20, 2025, at 10 AM EST.
    Small business Education and Entrepreneurial Development (SEED) Support Services
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide support services for the Small business Education and Entrepreneurial Development (SEED) initiative. This procurement aims to enhance the navigation of the laboratory-to-market pipeline for biomedical innovators by offering targeted regulatory and commercialization support, as well as educational resources to improve outcomes for NIH-funded projects. The SEED office plays a crucial role in advancing discoveries into products that benefit patient health, aligning with NIH's strategic objectives to foster innovation in the life sciences. Interested firms must submit their capability statements to Donald Ledwig at donald.ledwig@nih.gov by January 24, 2025, at 3:00 PM, with no telephone inquiries accepted.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services to support the development of drug products. The objective of this procurement is to ensure the delivery of high-quality formulated drug products for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic development. This opportunity encompasses a wide range of services, including formulation development, manufacturing under current Good Manufacturing Practices (cGMP), and necessary testing to meet regulatory standards. Proposals are due by February 3, 2025, with a contract period extending from September 30, 2025, to July 31, 2031, and a maximum funding amount of $49,885,703. Interested parties can contact Michelle Cecilia at michelle.cecilia@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.
    CIVICs Data Management and Coordinating Center (DMCC)
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to provide services for the renewal of the CIVICs Data Management and Coordinating Center (DMCC). The DMCC will support the CIVICs program by managing data, conducting analyses, and facilitating communication and coordination among various stakeholders, with a focus on advancing influenza vaccine research and development. This initiative is critical for enhancing the immunogenicity and durability of seasonal influenza vaccines and involves the operation of a scalable data management system, maintenance of public and private portals, and comprehensive program coordination. Interested parties must submit their tailored Capability Statements by 3:00 PM (Eastern Time) on January 23, 2025, to Maribel Miranda at maribel.miranda@nih.gov, with the anticipated contract award date around July 2026.
    Fiber Photometry Processors
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information from small businesses regarding their capabilities to provide Fiber Photometry Processors, particularly the RZ5P model, which is essential for data acquisition and processing in the study of substance use disorders. The processors will be used to record neurotransmitter activity, such as dopamine, during behavioral experiments and substance administration, contributing to the understanding of substance use disorder mechanisms. Interested small businesses, including those classified as HUBZone, service-disabled veteran-owned, and woman-owned, are invited to submit a capability statement detailing their qualifications and relevant experience by January 29, 2025. For further inquiries, potential respondents can contact Joseph Kennedy at joseph.kennedy@nih.gov or Marlene Milgram at marlene.milgram@nih.gov.
    A--Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (B
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Institute of Child Health and Human Development (NICHD), is seeking qualified small businesses to support the Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (BPCA). The primary objective of this procurement is to provide comprehensive data management, analysis, and regulatory reporting services for pediatric clinical trials, ensuring compliance with FDA regulations and facilitating data submission to the FDA and the NICHD Data Repository. This initiative is crucial for enhancing pediatric health outcomes by addressing therapeutic gaps and conducting necessary clinical studies, as mandated by the reauthorized BPCA. Interested parties must submit their capability statements by January 28, 2025, and can contact Deborah Brock at Deborah.Brock@nih.gov for further information.