|Agency:||HEALTH AND HUMAN SERVICES, DEPARTMENT OF|
|Type of Government:||Federal|
|Set Aside:||Original Set Aside:|
|Posted Date:||Feb 2, 2021|
|Bid Source:||Please Login to View Page|
|Contact information:||Please Login to View Page|
|Bid Documents:||Please Login to View Page|
The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Allergy, Immunology, and Transplantation has a requirement for a clinical site monitoring center.
Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) supports extramural basic, pre-clinical, and clinical research focusing on protective immune responses and immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to 1) evaluate the safety and efficacy of therapeutic and preventive approaches and agents, and 2) elucidate the underlying mechanisms of such approaches and agents.
A critical component of DAIT’s awarded grants and contracts involves the design and conduct of clinical research studies, including Phase 1 through 4 clinical trials of investigational approaches, intended to lead to a functional state of immune tolerance in three main clinical areas: autoimmune diseases; asthma and allergic diseases; and immune-mediated rejection of transplanted solid organs, tissues, and cells.
Purpose and Objectives
The purpose of this acquisition is to:
2. Advance the field of risk-based monitoring through innovation using novel and effective approaches, with the goal of ensuring participant safety, quality data, and greater site/study compliance.
The Contractor shall provide comprehensive clinical site and study monitoring services for a broad range of NIAID-sponsored and/or -funded clinical research (including but not limited to clinical trials) for both domestic and international research. The contractor will be responsible for:
NIAID anticipates making a single term, level-of-effort (LOE), severable award. The total performance period, comprised of the base plus optional periods, is seven (7) years: 1 Base Year plus six (6) 1-year Options.
The award is anticipated to be made on or around January 1, 2022.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about February 18, 2021, and may be accessed through beta.SAM.gov. This notice does not commit the Government to award a contract.
No collect calls will be accepted. No facsimile transmissions will be accepted.
For this solicitation, the NIAID requires proposals to be submitted via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable.
For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."
|Sep 1, 2020||[Sources Sought (Original)] National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC)|
|Sep 2, 2020||[Sources Sought (Updated)] National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC)|
|Feb 24, 2021||[Solicitation (Original)] National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC)|
|Apr 8, 2021||[Solicitation (Updated)] National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC)|
|Apr 23, 2021||[Solicitation (Updated)] National Institute of Allergy and Infectious Diseases (NIAID) Clinical Site Monitoring Center (CSMC)|
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