SOLICITATION NOTICE
A -- AUTOIMMUNE DISEASES STATISTICAL & CLINICAL COORDINATING CENTER
- Notice Date
- 8/5/2020 12:41:05 PM
- Notice Type
- Presolicitation
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIAID BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- I-2211
- Response Due
- 8/20/2020 12:00:00 PM
- Archive Date
- 09/04/2020
- Point of Contact
- Anuj Patel, Liem Nguyen
- E-Mail Address
-
anuj.patel@nih.gov, liem.nguyen@nih.gov
(anuj.patel@nih.gov, liem.nguyen@nih.gov)
- Description
- 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 (DAIT) has a requirement to solicit offers for a contract to support a broad range of services critical for the design, development, execution, and analysis of clinical research in autoimmune diseases. The major clinical research programs to be supported by this solicitation include, Autoimmunity Centers of Excellence and Immune Tolerance Network (ACE), as well as investigator initiated clinical trials (IICT), and other clinical trials or study activities supported by NIAID herein collectively referred to as NIAID supported research. Description The Contractor shall establish an Autoimmune Diseases Statistical & Clinical Coordinating Center (AD-SCCC) that will provide a broad range of support critical for the design, development, execution, and analysis of clinical research sponsored by NIAID in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. The scope of clinical research to be supported by the AD-SCCC includes: (i) clinical trials at all phases to evaluate the safety and efficacy of investigational products and innovative approaches for disease treatment and prevention; (ii) studies of underlying mechanisms as integral components of clinical trials; (iii) clinical studies (e.g., genetic studies, microbiome studies, surveys of current therapies, etc.); and (iv) surrogate/biomarker studies. The scope of statistical and clinical support functions to be performed by the AD-SCCC include: statistical design and analysis; protocol development; study initiation and management; clinical safety and pharmacovigilance support; safety oversight; management of clinical study collaboration portals; manuscript preparation and management of sample repositories. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 08/20/2020, 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.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c303a7ffe7214312be5c9e7496947f72/view)
- Record
- SN05745746-F 20200807/200805230153 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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