Applied Clinical Trials
Montrium, a â¯cloud-based software solutions for the life sciences, has shared that technology partner Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit research organization, has advanced to their Phase III MAPP2 study with the support of Montrium’s eTMF Connect trial master file solution.
Headquartered in Santa Cruz, California, MAPS is advancing from MAPP1, the study carried out in Phase III, to a global confirmatory MAPP2 study to assess the safety and efficacy of MDMA-assisted psychotherapy for patients with post-traumatic stress disorder (PTSD). Launching screening in July 2020, MAPP2 represents the progression of the largest, most advanced clinical trial to date of psychedelic-assisted therapy, with 14 sites planned across the US, Israel, and Canada. MAPS will begin PTSD trials in Czech Republic, Netherlands, and Norway this year.
“MAPS was aware of its path towards NDA and commercialization, and well understood the steps it needed to achieve that with its first Phase III clinical trial, including the need to implement new clinical systems. eTMF Connect has provided a compliant, organized, secure system to house our TMF and make sure we are audit-ready,” said Maryann Böger, Clinical Quality Assurance Manager at the MAPS Public Benefit Corporation (MAPS PBC), a wholly owned subsidiary of MAPS.
Given a growing global study program with the advancement of MAPP2 in the Phase III clinical trial, eTMF Connect has helped better enable MAPS’ teams to collaborate remotely, work more efficiently, and have better visibility into TMF metrics, all within a compliant system that accounts for various global regulations.
“We are extremely proud of our long-standing partnership with MAPS and how eTMF Connect has contributed to advancing their Phase III study. Currently, we are working with MAPS to configure eTMF Connect to accommodate Program-Level documents, so they apply across affiliated studies, sparing the time and effort to file a single document repeatedly. While the solution is designed with comprehensive clinical eTMF functionality, we strive to offer a powerful document tool directly suited for our clients’ needs,” said Christina Mantzioros, Director of Customer Experience at Montrium.