PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (pSMILE)
ID: SBSS75N93025R00011Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIAIDBETHESDA, 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)

Original Source

https://sam.gov/opp/2cf06d5d9eb14f2c9b67e524f368feb3/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking qualified small businesses for a contract related to Patient Safety Monitoring in International Laboratories (pSMILE). The objective of this procurement is to enhance the capabilities of non-U.S. laboratories in conducting clinical trials in accordance with good clinical laboratory practices (GCLP), ensuring reliable test results and compliance with regulatory standards. The anticipated contract will support approximately 150 labs across 18 countries and includes key activities such as auditing lab compliance, supporting method validations, training laboratory staff, and managing a secure electronic repository for lab documentation. Interested organizations must submit detailed capability statements to demonstrate their expertise and relevant experience, with the contract expected to last for one base year and include six one-year options, potentially extending to a total of seven years. For further inquiries, contact Patrick Finn at patrick.finn@nih.gov or Robert Corno at cornorj@niaid.nih.gov.

    Files
    Title
    Posted
    Sources Sought Notice for SAM.pdf
    The document is a Small Business Sources Sought notice from the National Institute of Allergy and Infectious Diseases (NIAID), aimed at gathering information on qualified small business sources for a contract related to Patient Safety Monitoring in International Laboratories (SMILE). The purpose is to identify small businesses that can enhance the capabilities of non-U.S. laboratories in conducting clinical trials according to good clinical laboratory practices (GCLP). The current contract supports approximately 150 labs in 18 countries and emphasizes the importance of providing reliable test results while ensuring compliance with regulatory standards. Key activities of the SMILE contract include auditing lab compliance, supporting method validations, training laboratory staff, and managing a secure electronic repository for lab documentation. The anticipated contract duration is one base year with six one-year options, potentially extending to a total of seven years. Responding organizations must submit detailed capability statements, demonstrating their expertise and relevant experience. This notice serves as a pre-solicitation for gathering capabilities rather than a call for proposals, helping the government assess potential small business participation in its clinical research initiatives.
    Lifecycle
    Title
    Type
    PATIENT SAFETY MONITORING IN INTERNATIONAL LABORATORIES (pSMILE)
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