Exom Group is proud to announce that the results of CARAVAGGIO, a practice-changing study, have been presented at the ACC Virtual 2020 and published on the NEJM on March 29th, 2020.
The study involved 159 clinical sites distributed in 9 European countries plus Israel and USA, who recruited 1.170 patients in less than 26 months.
In spite of the huge amount of data to be processed such as > 3,500 AEs and > 15,000 concomitant medications reported and coded and > 1,200 clinical events reported and adjudicated by the Central Endpoint Committee, we have been successful in completing all data management, statistics and paper writing activities in 20 working days from last patient last visit (LPLV) to manuscript submission to the NEJM for publication.
Such a stunning performance has been possible because of Exom digital approach to the study conduction and management through the use of Genius SUITE platform as depicted in the slide below.
With the support of those listed digital applications Exom met the following performance metrics :
- completion of 296 international site feasibilities in less than 3 months after contract signature
- application to the first national coordinating EC in less than 2 months after contract signature
- First site ready to start patient’s randomization in 3.5 months after EC submission
- Data base closure in 14 working days from LPLV
This case study clearly proves that performance, quality and timelines that are the major drivers in clinical trials can be successfully managed through the implementation of digital solutions combined with experienced personnel.
Exom Genius SUITE offers a fully integrated set of tools, ranging from eFeasibility, eTMF over eICF and eCRF up to remote patient’s monitoring and Advanced Analytics, supporting the study staff in managing clinical trials successfully and efficiently.
Our experience proves that full digital not only assures trial integrity and continuity in challenging times such as during the Covid-19 pandemic, but also allows the conduction of studies more efficiently in terms of costs, speed and quality.