SOLICITATION NOTICE
A -- AUTOIMMUNE DISEASES STATISTICAL & CLINICAL COORDINATING CENTER
- Notice Date
- 9/3/2020 1:52:22 PM
- Notice Type
- Solicitation
- 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
- 12/18/2020 12:00:00 PM
- Archive Date
- 12/31/2020
- 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
- AMENDMENT 1: The purpose of this amendment is to remove�erroneous� information�in Section L. item 1.b. Notice of Small Business Set-Aside from�page 53/146 of the RFP.� This requirement�is not set-aside for Small Business.� An updated RFP No.� 75N93020R00012_REVISION 09032020 is attached. The purpose of this Request for Proposals (RFP) is 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 (ACE) and Immune Tolerance Network (ITN), 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. The Contractor shall establish an Autoimmune Diseases Statistical & Clinical Coordinating Center (ADSCCC)�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 ADSCCC�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 includes 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. See Attachment 3, Statement of Work, for details.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/f25c7bf7a661422195313bd48f69ce44/view)
- Place of Performance
- Address: USA
- Country: USA
- Country: USA
- Record
- SN05785851-F 20200905/200903230154 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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