Building on Success of BARDA’s Clinical Studies Network- 24-BARDA-CSM-RFI-001

Background
The Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), is seeking information on how Contract Research Organizations (CROs) could assist the United States Government (USG) with Medical Countermeasure (MCM) development, preparedness, and response by forming Clinical Research Centers (CRCs). BARDA is tasked with improving preparedness and response through public-private partnerships that advance research and development, manufacturing, and procurement of MCMs that protect against health security threats such as chemical, biological, radiological, and nuclear (CBRN) incidents, pandemic influenza, COVID-19, and emerging and re-emerging infectious diseases.

Work Details
The BARDA CRCs will conduct interventional and non-interventional clinical studies and Phase 0, I, II, III, and IV clinical trials both domestically and globally in compliance with all applicable federal and local regulations. Their service capabilities will include project management, statistical support, study design, data management, site training and support, laboratory services, regulatory services including Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) publishing and FDA submission, Institutional Review Board (IRB)/Independent Ethics Committee (IEC) services, quality assurance, secure web portal for communication and document sharing/reviews. Additional services will include data mining capabilities to identify and monitor epidemics of influenza and emerging infectious diseases.