SAN FRANCISCO, CA--(Marketwired - April 18, 2017) - The Multidisciplinary Association for Psychedelic Studies (MAPS), a California-based non-profit research organization, has selected Medrio, a Software as a Service (SaaS) company offering electronic data capture services to clinical trials, as its data management system for a Phase 3 clinical trial testing the efficacy and safety of MDMA-assisted psychotherapy as a treatment for post-traumatic stress disorder (PTSD). MAPS has utilized Medrio for its research in the past, but the new agreement represents its first purchase of the full range of modules in Medrio's software, including eSource, randomization, dictionary coding, and others. The agreement will commence in 2018 and remain in place until 2020. In preparation for the Phase 3 studies, MAPS is currently hosting their Phase 3 Investigator Meeting in Oakland, CA.
The agreement is a result of Medrio's consistent and demonstrated ability to deliver various benefits to researchers at MAPS. These include, but are not limited to:
- The ease of implementing Medrio and the convenience of its cloud-based infrastructure
- Medrio's ability to accommodate the various complexities of the upcoming study's protocol
- MAPS researchers' ability to reuse relevant data entered in previous studies
- The positive feedback on Medrio from data managers, site staff, and monitors who have used the system in prior MAPS studies
- The stability of Medrio's CFR Part 11 compliance compared to other systems MAPS has used in the past, which have required frequent validation and management
MAPS is confident that these features and others will best equip its researchers to maximize success amid the many challenges inherent in Phase 3 clinical trials.
The Phase 3 trial comes on the heels of six completed Phase 2 studies sponsored by MAPS -- four of which used Medrio -- in which MDMA showed promise as a treatment for PTSD when used in combination with psychotherapy in a controlled clinic setting. In those studies, a majority of participants who received an active dose of MDMA-assisted psychotherapy ceased to meet the criteria for PTSD, as opposed to only a minority of participants who received the comparator dose. Improvements were durable for 12 months after treatment in 91 participants on average. These results are encouraging for those researching and suffering from PTSD, a widespread condition for which treatment has historically been elusive.
"PTSD is a huge problem for which there is still no clear solution. Other medications haven't been effective, and military veterans suffering from PTSD often don't have access to sufficient therapy through the Department of Veterans Affairs," said Amy Emerson, Executive Director and Director of Clinical Research at the MAPS Public Benefit Corporation. "After seeing positive results in Phase 2, we realized MDMA could represent a breakthrough in PTSD treatment, and knew we'd need the best data management tools available as our research continues. That's why we've elected to expand our partnership with Medrio for this pivotal Phase 3 study."
Of the new agreement, Mike Novotny, founder and CEO of Medrio, said, "The researchers at MAPS are on their way to breaking new ground in the treatment of PTSD, and it's so exciting for us to be involved. We've always enjoyed our relationship with MAPS, and we're honored to be lending them our services in a new capacity for this incredibly innovative and important project."
The MAPS Public Benefit Corporation (MPBC) is a wholly owned subsidiary of the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS). MPBC's primary work is to support MAPS' mission by conducting studies to support the development of MDMA-assisted psychotherapy into an approved treatment for PTSD.
MPBC's mission is to develop psychedelics and marijuana into prescription medicines, and to support scientific research by training therapy teams and educating the public honestly about the risks and benefits of psychedelics and marijuana. MAPS raises funds for MPBC projects, and serves as parent organization and sole funder of MPBC. MPBC was incorporated on December 19, 2014.
Medrio offers an integrated eClinical software platform with a fully hosted EDC system. Our revolutionary CloudEDC™ technology features an easy-to-use drag-and-drop interface, allowing study managers to build their studies in days instead of months without requiring any programming. Medrio's new mobile suite, mSource, supports both event-based and subject-based workflows, offline data entry, and Patient Reported Outcomes (PRO). Although Medrio has extensive experience in all study phases, our m1 application leads the way in early-phase and Phase I trials, with over 500 Phase I trials to date. Medrio costs up to 75% less than traditional EDC solutions. For more information, please visit our website. To schedule a demo, please submit your information here and a member of our team will be in touch shortly.