CIVICs Statistical, Data Management and Coordination Center (SDMCC)

Solicitation has been posted

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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 Divisions of Allergy, Immunology and Transplantation (DAIT) and Microbiology and Infectious Diseases (DMID) have jointly developed the Collaborative Influenza Vaccine Innovation Center (CIVICs) program (HHS-NIH-NIAID-BAA2018 Amendment 1) to advance the production of improved seasonal and universal influenza vaccines that provide durable, broadly cross-protective immunity. This current solicitation supports the establishment of a Statistical, Data Management and Coordination Center (SDMCC) that will provide statistical support, data management and analysis, and preclinical/clinical study coordination services for the CIVICs program, which includes at least two (2) Vaccine Centers, responsible for design/development and comprehensive immunologic evaluation of candidate influenza vaccines both preclinically and clinically; a Vaccine Manufacturing and Toxicology Core, which manufacture, formulate, optimize, and evaluate the safety and toxicity of the innovative vaccine platforms and approaches developed by the Vaccine Centers; and a Clinical Core, which will conduct vaccine and human challenge trials.
Description
The Contractor shall establish and manage a Statistical, Data Management and Coordination Center (SDMCC) that will support the CIVICs network program through: facilitating statistically sound preclinical and clinical study design; enabling data analyses and data sharing across the CIVICs network program; conducting/coordinating submission of CIVICs data and meta-data to NIAID-designated public repositories; developing and maintaining a CIVICs public portal; tracking and sharing of CIVICs-generated samples, reagents, resources, and standard operating procedures (SOPs) across the CIVICs network program and with the broader research community; and managing initiation, conduct, and tracking of CIVICs-related clinical trials and human challenge studies.
Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 31, 2018 and may be accessed through FedBizOpps http://www.fedbizopps.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 online via the NIAID electronic Contract Proposal Submission (eCPS) website. 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."

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