THOR Research Institute (TRI)

ABOUT The THOR Network Foundation The THOR (Trauma Hemostasis & Oxygenation Research) Network Foundation is a US-based 501(c)(3) public charity organization. It’s members are an international multidisciplinary network of civilian and military providers ranging from first responders and medics to physicians from multiple disciplines, as well as basic scientists, bioengineers, and clinical trialists. The international influence of THOR is evidenced by our membership of over 600 subject matter experts and industry leaders from over 31 countries from 6 continents. OUR MISSION: To develop and implement best practices for prehospital damage control resuscitation in trauma care through to the completion of the acute phase of hemorrhagic shock resuscitation at higher echelons of care. The THOR Network will execute this mission through a multidisciplinary collaborative approach to research, education, training, and advocacy. See www.thornetwork.com for more information about the THOR Network, its foundation, and the Research Institute. The THOR Research Institute (TRI) The THOR Research Institute (TRI), LLC is a subsidiary of the THOR Network Foundation. The purpose of the TRI, LLC is to facilitate medical research to improve patient outcomes in furtherance of Code Section 501(c)(3). The TRI is a Research and Development Institute specializing in translational research and advisory services. It is comprised of investigators that span the translational research pipeline that includes basic science, clinical trials, implementation science. The TRI is unique compared to many other research institutes and consulting groups in that its investigators and advisors are members of a large international multidisciplinary network with a balanced mix of established investigators, and advisors with extensive clinical experience, practical understanding, and knowledge of clinical care required for patients with hemorrhagic shock. THOR and the TRI have demonstrated its ability in performing high quality science challenging long standing dogma in resuscitation medicine that has led to substantial change in practice and improving outcomes globally. The TRI is eligible to submit funding applications for federal funding in the US for projects initiated by TRI investigators. The TRI also collaborates internationally with academia, industry, and federal agencies to perform translational research in the area of resuscitation science to support licensure applications for devices and biologics. While research and development of diagnostics and therapies for trauma-related hemorrhage is our main focus we have an interest in all etiologies of life-threatening bleeding and the use of blood products for resuscitation. TRI Capabilities/Services include the following: 1. Product and Device Development a. Program and Project Management i. Government Contracting Liaison (BARDA, DARPA, DoD) b. Chemistry, Manufacturing, and Controls development c. Right-sized Quality System development d. Pre-clinical program development for products or devices 2. Clinical Research Organization Services a. Clinical study operations for phase 1 through phase 4 trials. i. Trial design ii. Protocol development and operationalization iii. Clinical trial site identification, feasibility, qualification, selection and qualification iv. IRB/ethics and regulatory management b. Clinical program external review 3. Regulatory a. Interface, including correspondence with regulatory authorities as well as authoring and reviewing of pre-IND, IND, NDA, and BLA documentation. b. Experience with global regulatory authorities (TGA, EU, Health Canada, ANVISA) c. CDER, CBER, CDRH 4. Educational a. Development of webinars for educational purposes b. Development of focused scientific symposia 5. Consulting or advisory a. Development of advisory boards for industry, investment firms, and government entities b. Product assessment by end users for practical feedback on military and civilian applications, functionality, and potential for widespread adoption. c. Market analyses, including survey development and dissemination