PRINCETON, N.J., Sept. 9, 2020 /PRNewswire/ — Bioclinica, an integrated solutions provider of clinical life science and technology expertise, delivering powerful insight into clinical trial development in bringing new therapies to people worldwide, announced today that Direct Biologics, a market leading innovator and science-based manufacturer of regenerative products, will leverage Bioclinica’s Interactive Response Technology (IRT) for their EXIT COVID-19 study — a multi-center FDA phase II clinical trial for the use of ExoFlo™ to treat COVID-19 acute respiratory distress syndrome (ARDS).
“We are a dynamic and innovative biotechnology company that can engage synergistically with vendor partners who are willing and able to match our speed and adaptability in our efforts to deliver solutions for highly complex and pressing real world problems,” said Dr. Vik Sengupta, Chief Medical Officer of Direct Biologics. “Bioclinica’s ability to rapidly configure their highly robust and functional IRT made them the natural choice to meet our accelerating timeline in the fight against COVID-19. The Bioclinica team rose to the occasion, scaling with demand, and accommodating our specific randomization and supply chain requirements.”
Bioclinica’s IRT is the industry’s only system that provides advanced visibility to working study prototypes within just a few days – letting you build, implement, test, and deploy new protocols in as little as two to three weeks, with or without customization.
“This implementation is further proof of Bioclinica’s agility in servicing our customers across the entire project lifecycle,” explained Ehsan Ramezani, Senior Director, Clinical Solutions at Bioclinica. “From the initial contact with the client to our expert analysis of the protocol, contract execution processes, organization of the project kick-off meeting, and implementation of the system, Bioclinica provides proactive tools that provide the perfect solution at the right price and the right time.”
Bioclinica is an integrated clinical life science solutions provider, delivering powerful insight into clinical trial development, assuring greater client success in bringing medical therapies to market, for people around the world. Through deep medical, scientific and technology expertise, the company provides medical imaging and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments; clinical trial management software; and drug safety solutions. Bioclinica’s global team of life science experts serve more than 500 pharmaceutical, biotechnology and device organizations – including the top 20 biopharmaceutical companies and leading CROs – through offices in North America, Europe, and Asia. For more information, visit www.bioclinica.com.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologic’s management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA’s investigational new drug application process. For more information, visit www.directbiologics.com.