The US Department of Health and Human Services, National Institutes of Health, National Institute of Allergies and Infectious Diseases (NIAID) has a continuing requirement for Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID) support services.

esearch supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), strives to understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents, an essential component of U.S. efforts to ensure the health and safety of the American people. Through multiple grant- and contract-funded research programs, NIAID supports a broad range of clinical research, including single-site and multi-center trials spanning Phase 0-4 therapeutics and vaccines, new vaccine formulations, schedules, and modes of delivery; surveillance or natural history / cohort studies for pathogens of interest; evaluation of novel diagnostics; and clinical trials designed to find additional uses for already approved therapies for selected infectious diseases. The portfolio includes primarily domestic clinical sites, with the ability to support international studies.

As part of clinical research portfolio, NIAID has regulatory obligations for clinical trials that include standardized deliverables, reporting, safety oversight, and monitoring. NIAID therefore requires resources to support its clinical research activities in compliance with regulatory requirements. One of those resources is a Statistical and Data Coordinating Center (SDCC) which provides centralized data management, statistical, and specimen tracking services essential to this clinical research portfolio. NIAID is exploring the re-competition of its Statistical and Data Coordinating Center (SDCC) for Clinical Research in Infectious Diseases (CRID) contract.

• The contractor will operate and maintain a state-of-the-art, 21 CFR Part 11-compliant clinical data system supporting data collection, automated data transfer, validation, storage, and submission to the FDA, from a large portfolio of domestic clinical sites, with the ability to support international studies.
• The contractor shall provide and maintain a quality control system for monitoring the accuracy, completeness, and timeliness of the data, by study sites at each stage of a study, beginning with study initiation/participant enrollment and proceeding to the generation of final data sets. The system shall provide for verification of 100 percent of study data for audit readiness.
• The contractor shall provide services in the preparation, writing, review, revision, and distribution of protocol-related documents and materials (i.e., Manual of Procedures (MOP)) in collaboration with the study team and in support of implementation of the clinical protocol.
• The Contractor shall coordinate and collaborate with NIAID and other NIAID Clinical Research Infrastructure contractors and grant recipients to facilitate study implementation and assess study progress. The Contractor shall operate and maintain a web-based resource to share clinical research information and study materials with the NIAID, the study team, and participating study sites.
• The Contractor shall provide expertise, advice, and assistance in the development of statistical designs of clinical concepts, statistical analysis plans, and in preparation of interim and final analyses for clinical research activities.
• The Contractor shall train clinical site personnel on data systems and procedures, maintain a 24/7 help desk accessible from domestic and international locations, and assess site capabilities for studies not using SDCC systems.
• The Contractor shall provide and maintain an electronic specimen tracking system, for use by the SDCC, study sites, laboratories, and NIAID, to track study specimens in real time.
• The contractor shall maintain a secure and validated data storage system for clinical research and clinical trial data and analyses from current and future trials.
• The contractor shall distribute, transfer, and/or share data and metadata to NIH and NIAIDdesignated repositories following completion of the clinical trial while ensuring data are appropriately and commensurately de-identified.
• The contractor shall provide for the overall management, integration and coordination of all contract activities, including the management and coordination of activities carried out under subcontracts if applicable