Inactive

AMENDMENT No. 4 The purpose of this amendment is to correct a typo in the response to question No. 7 included in the Amendment No. 3 published on December 9, 2020. AMENDMENT 3: The purpose of this Ame... AMENDMENT No. 4 The purpose of this amendment is to correct a typo in the response to question No. 7 included in the Amendment No. 3 published on December 9, 2020. AMENDMENT 3: The purpose of this Amendment #3 is to provide responses to the questions submitted by potential offerors, per see attached Amendment 3 for details. This Amendment #3 also provides a SOW_Amendment 3, revising the numbering order of sections C., D., and E. in pages 4-6 of the RFP. AMENDMENT 2: The purpose of this amendment is to provide responses to the questions submitted by potential offerors, per see attached Amendment 2 for details. 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.

Inactive

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 und... 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.