Statistical and Data Coordinating Center (SDCC) for Clinical Research in…

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY In accordance with RFO 15.101(c), this RFI is issued solely for information and planning purposes. It does not constitute a solicitation for proposals, quotations, or abstracts, nor does it obligate the Government to award a contract or pay for any information provided. Responses will not be returned. No reimbursement will be made for costs associated with responding to this notice. 1. Background Research 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. 2. Purpose The Government is issuing this RFI to: Facilitate early engagement with industry prior to release of a formal Request for Proposals (RFP), in accordance with RFO 15.101(c). Assess current market capabilities and vendor offerings relevant to SDCC services. Gather input on industry best practices to inform development of a future Statement of Work (SOW). Support fair and open competition in accordance with FAR 5.401. 3. Summary of Anticipated Scope and Targeted Feedback The anticipated SDCC contract encompasses the following broad functional areas. Respondents are encouraged to provide specific feedback on each area, including comments on feasibility, gaps, ambiguities, industry best practices, and any suggested refinements. 3.1 Overall Questions Targeted feedback requested: To what extent can or should Artificial Intelligence (AI) tools or platforms be incorporated into the SOW while maintaining confidentially of participant data? 3.2 Data Collection and Management 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. Targeted feedback requested: What commercial or proprietary platforms are best suited to support a portfolio of this scale and diversity while also meeting the standards of government-funded computer systems and Food and Drug Administration (FDA) regulatory submissions? What are their strengths and limitations in: an international setting; multi-site protocols; multi-protocol environments; and data collection methods from multiple sources, including electronic health records (EHR), electronic source, and paper source? How should the Statement of Work (SOW) address data system transition and continuity of operations at contract start-up to minimize disruption to ongoing studies? 3.3 Data Quality Assurance and Control 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. Targeted feedback requested: What contractor involvement with development of data standards (i.e., via CDISC working groups and committees) should the SOW require to ensure innovation and continuous improvement in how data are collected? As CDISC and other standards continue