Medidata and Mapi Research Trust (MRT) Announce Strategic Collaboration to Standardize eCOA Global Library of Questionnaires

Medidata (NASDAQ: MDSO) and Mapi Research Trust today announced a new critical mission: to build a digital, global library of pre-configured and pre-approved eCOA (clinical outcomes assessment) questionnaires. The collaboration will create reusable versions of MRT distributed questionnaires in Medidata Rave eCOA, collecting COA data from hundreds of studies each year on the Medidata platform.

"This new collaboration with MRT will seek to solve two major eCOA implementation struggles that affect the pharmaceutical industry - the rework involved in building the same questionnaire in multiple studies for different sponsors, and the timelines required for deploying translated versions across global trials,” said Glen de Vries, president, co-founder, Medidata. "MRT’s licensing and author relationships, combined with Medidata’s expertise and eCOA solution, will drive significant efficiencies in study management, empowering sponsors to create more patient-centric clinical trials.”

The collaboration will allow Medidata and MRT to engage with instrument authors and study sponsors, resulting in questionnaires that are pre-approved, translated for global implementations, and archived for future use. Based on this innovative approach, the comprehensive new eCOA library will include:

• 470+ questionnaires and 7,000 translations representing 190 instrument developers and owners within the Mapi Research Trust ecosystem
• Pre-approved agreements with instrument authors for faster study start acceleration and localized screenshots ready for IRB submission
• Security of Medidata’s Rave platform infrastructure and eCOA Solution already used on thousands of clinical trials each year around the globe

"Industry timelines from kick-off to go-live for eCOA studies have long been stuck at 12 to 16 weeks, because of repeated efforts rebuilding the same forms and translations over and over for different studies,” says Katrin Conway, Managing Director of Mapi Research Trust. "The Medidata and MRT global eCOA Library seeks to cut these timelines by as much as 50-60% by building a library of pre-approved questionnaires that Medidata customers on the Rave platform of products can use.”

About Medidata

Medidata is leading the digital transformation of life sciences, with the world's most-used platform for clinical development, commercial, and real-world data. Powered by artificial intelligence and delivered by industry experts, Medidata helps pharmaceutical, biotech, medical device companies, and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata and its companies, Acorn AI and SHYFT, serve more than 1,300 customers and partners worldwide and empower more than 150,000 certified users every day to create hope for millions of patients. Discover the future of life science: www.medidata.com

About Mapi Research Trust:

Mapi Research Trust was created as a non-profit arm of Mapi Group which was acquired by ICON plc in 2017, creating the world’s second largest provider of late phase services. Mapi Research Trust works in collaboration with academic researchers, life-science companies and regulatory bodies to support the industry in reducing the burden of implementing COA in Health research. It is the largest curator of Clinical Outcomes Assessments (COA) and their translations, the largest single COA licensing provider and the most trusted name in distribution of COA instruments representing over 350 exclusive questionnaires. Visit http://mapi-trust.org/ for more information.

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