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

Sources Sought Notice Information Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: the availability and capability of qualified small business sources; whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 the myriad infectious, immunologic, and allergic diseases that threaten millions of human lives. This mission is driven by two strategic aims: addressing major infectious diseases, including emerging and chronic infections, and tackling immunologic and allergic disorders. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents. This includes basic and applied research to develop and evaluate therapeutics, vaccines, medical devices, and diagnostics, which are funded through a variety of research grants and contracts. Through multiple grant- and contract-funded research programs, NIAID supports a broad range of clinical research, including single-center and multi-center Phase 0-4 clinical trials of therapeutics, including both novel agents and repurposed therapies; vaccines, new vaccine formulations, schedules, and modes of delivery; natural history and cohort studies for pathogens of interest; and evaluation of novel diagnostics for selected infectious diseases. These clinical research activities are focused on the improved diagnosis, treatment, and prevention of emerging, infectious, and chronic diseases for public health priorities that address the needs of the United States (U.S.) population. Purpose and Objectives The U.S. Government has a requirement for the establishment and management of a Statistical and Data Coordinating Center (SDCC) to support DMID s extramural clinical research programs. Project Requirements The project requirements of the SDCC include: 21 CFR Part 11-compliant clinical data management systems for the collection, storage, management, reporting and quality control of study data; preparation of study-related materials; clinical study websites; statistical design and analysis expertise; data management user training; support of study operations, clinical site capability assessment for data management; electronic specimen tracking system; data storage facility; and project/site management. Anticipated Period of Performance The Government anticipates making one (1) contract award. It is anticipated that the duration of the contract will be a maximum of seven (7) years. Other important considerations: Where permissible and appropriate, incorporation of Artificial Intelligence (AI) across the functions of the SDCC are anticipated to be permitted, while enforcing safeguards for participant privacy and regulatory compliances, in alignment with NIH policies and guidances, including Office of Science Policy s (OSP) Artificial Intelligence in Research: Policy Considerations and Guidance. Final decisions affecting clinical data shall remain subject to documented human review and quality control. Respondent…