Direct Biologics 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 a few days.
"This implementation is further proof of Bioclinica's agility in servicing our customers across the entire project lifecycle," said 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."