Request for Information (RFI): Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID)

The National Institute of Allergy and Infectious Diseases (NIAID) is seeking information from vendors regarding the provision of a Statistical and Data Coordinating Center (SDCC) for clinical research in infectious diseases. The SDCC will provide centralized data management, statistical, and specimen tracking services to support NIAID's clinical research portfolio. The scope of work includes data collection and management, data quality assurance and control, protocol and study-related materials development, statistical design and analysis, clinical site training and technical assistance, electronic specimen tracking, data storage, and data sharing. The RFI is seeking feedback from vendors on the feasibility, gaps, and ambiguities in the anticipated scope of work, as well as industry best practices and suggested refinements. • The SDCC will support a broad range of clinical research, including single-site and multi-center trials, surveillance or natural history/cohort studies, and evaluation of novel diagnostics. • The SDCC will provide services in the preparation, writing, review, revision, and distribution of protocol-related documents and materials. • The SDCC will operate and maintain a web-based resource to share clinical research information and study materials with NIAID, the study team, and participating study sites. • The SDCC will provide expertise, advice, and assistance in the development of statistical designs of clinical concepts, statistical analysis plans, and preparation of interim and final analyses. • The SDCC will train clinical site personnel on data systems and procedures and maintain a 24/7 help desk.