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, communication and collaboration, statistical design and analysis, clinical site training and technical assistance, electronic specimen tracking, data storage, and data sharing. Vendors are asked to provide feedback on the draft scope of work, including suggestions for industry best practices, and to provide information about their organization, relevant experience, technical capabilities, and international experience. • The SDCC will support a broad range of clinical research activities, including single-site and multi-center trials, surveillance or natural history studies, and evaluation of novel diagnostics. • The SDCC will provide services to support the implementation of clinical protocols, including data management, statistical analysis, and specimen tracking. • The SDCC will operate and maintain a web-based resource to share clinical research information and study materials with NIAID, study teams, and participating study sites. • The SDCC will provide training and technical assistance to clinical site personnel on data systems and procedures. • The SDCC will maintain a secure and validated data storage system for clinical research and clinical trial data and analyses.