International Phase II/III Clinical Trial on Covid-19 Vaccine
Milan (Italy), March 19, 2021 – Exom Group srl, the Full Service, Digital & Green CRO is proud to announce the start of subjects’ recruitment for the Phase II part of COVITAR, a multicenter international clinical trial testing the GRAd-COV2 Covid-19 Vaccine by ReiThera srl, Rome, Italy.
The high level of professionalism and dedication of our operational team, from regulatory to project management, data management, site monitoring and digital trial technology, allowed us to randomize the first dozen participants in less than 2 months after our initial involvement in the study and final protocol release.
COVITAR uses our most advanced digital solutions for clinical trials, such as the eTMF/eISF, the digital platform for Drug Supply Management, the electronic informed consent, the eDiary, the remote Source Data Verification and the Advanced Analytics & Machine Learning for a real-time Data-Driven Study Management and Risk-Based monitoring.
Ultimately, those subjects who will become positive to SARS-CoV-2 virus and must be confined at home will be constantly and daily monitored in their vital parameters and symptoms through our tele-medicine platform, Genius ROSA.
COVITAR is another major challenge that the Exom Group has accepted and successfully overcome through a combination of professional expertise, digital mindset, unique technology and great motivation and dedication to our customers.
For more information, please feel free to contact us.