Montrium, a growing leader in Electronic Trial Master file solutions, today announced an exciting new partnership with a groundbreaking non-profit research organization, Multidisciplinary Association for Psychedelic Studies (MAPS).
The FDA has recently granted Breakthrough Therapy Designation to MDMA for the treatment of Posttraumatic Stress Disorder (PTSD). MAPS also reached agreement with the FDA on the design of two Phase 3 clinical trials for MDMA-assisted psychotherapy in patients with severe PTSD through a Special Protocol Assessment (SPA). MAPS has selected Montrium’s Electronic Trial Master File solution (eTMF), eTMF Connect , to support these upcoming Phase 3 studies and subsequent clinical trials.
“With such positive results during our Phase 2 trials we were confident that we would receive approval by the FDA to initiate Phase 3 studies on a larger patient population.,” said Amy Emerson, Director of Clinical Research and Executive Director at MPBC Public Benefit Corporation. “We realized very early on that to scale our Phase 2 successes in the next step of our journey, bringing in the appropriate technology to support this activity would be key. By partnering with Montrium, we not only leverage a sophisticated and robust eTMF system, but a knowledgeable and dedicated partner in the clinical trial arena.”
Montrium’s eTMF Connect solution will help MAPS improve the efficiency of trial processes by managing documents, data, and clinical activities on a single cloud platform. Researchers and Clinical teams will now be able to access clinical documents and information in real-time significantly improving collaboration and transparency. In addition, MAPS also strengthens the partnership further by joining Montrium’s Customer Advisory Program to actively participate in the shaping Montrium’s product development roadmap.
“As a small team paving the way in MDMA-assisted psychotherapy, MAPS faces several key challenges as they begin to scale their successes in clinical treatments.”, said Paul Fenton, President & CEO of Montrium. “We are extremely excited to have been selected to help support the great work the MAPS team is doing as they overcome these challenges and ensure the valuable research they are conducting reaches those in need.”
About eTMF Connect
Montrium’s proven eTMF Connect solution helps life sciences companies better manage their clinical trial documentation. It has been designed using the TMF Reference Model, and centralizes and standardizes your clinical records enabling both sponsors and CRO’s to contribute and access important clinical documents and information in real-time. You can learn more about eTMF Connect by visiting www.montrium.com/etmf-connect
Montrium is a global leader in cloud-based document & quality management solutions and GxP consulting services for the Life Sciences. Operating in the Life Sciences for over 10 years, Montrium has been successfully helping organizations implement and maintain technology to improve their business processes and increase compliance. Montrium currently serves over 8000 users in more than 20 countries. For more information on the products and services Montrium provides, please visit: www.montrium.com.
About MPBC and MAPS:
Founded in 1986, MAPS is a 501(c)(3) non-profit research and educational organization that develops medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana. Since its founding, MAPS has raised over $43.7 million for psychedelic therapy and medical marijuana research and education. For more information, visit MAPS.org
MAPS-sponsored clinical trials are conducted by the MPBC Public Benefit Corporation (MPBC), a wholly owned subsidiary of MAPS formed in 2015 for the special purpose of balancing social benefits with income from legal sales of MDMA, other psychedelics, and marijuana. For more information, visit MPBCbcorp.com
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