Resuscitation and Prevention of Ischemia-Induced Dysfunction (RAPIID) - TA3

The RAPIID program seeks to develop a complete, deployable, and authorized system that can save lives in the field by providing a blood analog system that can replace whole blood. The program will focus on pushing high technology readiness level (TRL)/medical readiness level (MRL) capabilities through the regulatory process by funding studies to demonstrate safety and efficacy of blood analog components and their ability to work in combination. The TA-3 performer will provide unified, in-house capabilities and accountability for all regulatory, clinical, and preclinical activities, including preclinical evaluation, regulatory sponsorship, clinical trial design and execution, data integrity and program management, and peer-reviewed dissemination. Key activities include: * Conducting combination testing of blood analog components to confirm safety and efficacy when administered together * Acting as the Sponsor of Record for all Investigational New Drug (IND), Investigational Device Exemption (IDE), and other regulatory document submissions to the FDA * Designing, sponsoring, and conducting multi-site Phase I and Phase II clinical trials * Maintaining responsibility for all regulatory, clinical, and data management activities * Publishing results from completed trials in peer-reviewed journals * Engaging directly with the Joint Trauma System and relevant civilian organizations to translate trial results into actionable clinical practice guidelines (CPGs) for rapid doctrinal adoption.