IPP: AUTOIMMUNE DISEASES STATISTICAL AND CLINICAL COORDINATING CENTER (ADSCCC)

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Contract supports a broad range of statistical and clinical support for the design, development, execution, and analysis of clinical research in autoimmune diseases and diseases related to mucosal immunology and primary immune deficiencies. Clinical research to be supported 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. Functions to be performed 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.