ALLERGY and ASTHMA, STATISTICAL & CLINICAL COORDINATING CENTER   3

Presolicitation Notice Information

Introduction
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 for Asthma and Allergic Diseases Statistical & Clinical Coordinating Center (AA-SCCC) which will provide a broad range of support critical for the design, development, execution, and analysis of clinical research sponsored by DAIT in allergic diseases and asthma.

Description
The Contractor shall establish an Asthma and Allergic Diseases Statistical & Clinical Coordinating Center (AA-SCCC) which will provide a broad range of support critical for the design, development, execution, and analysis of clinical research sponsored by DAIT in allergic diseases and asthma. The clinical research to be supported by the Center 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) observational clinical studies (e.g., longitudinal birth cohort studies, genetic studies, studies designed with the main purpose to assess mechanisms of disease etc.); and (iv) surrogate/biomarker studies. The scope of statistical and clinical monitoring functions to be performed by the Center includes statistical design and analysis, protocol development, study initiation and management and management of sample repositories.

The statistical and clinical support functions are currently being performed by Rho Federal Systems Division, Inc. (Rho), as described in RFA-AI-14-016 will be transitioned to the awardee of this contract. Currently, the clinical databases are managed through Medidata's cloud-based Rave Electronic Data Capture (EDC) software (https://www.medidata.com/en/audience/data-management/), while the safety database is managed thru Oracle Argus On-Premise Enterprise software .

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about 8/20/20 and may be accessed through beta.sam.gov http://www.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. Submission of proposals by facsimile or email is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."