Medidata and Oxford University Innovation’s Clinical Outcomes Team Announce Addition of Gold Standard Questionnaires to eCOA Library

Medidata and its customers gain access to pre-configured, pre-approved questionnaires in multiple languages to support clinical study start-up, quality, and efficiency

LONDON, UNITED KINGDOM - 12 November 2020 - Medidata, a Dassault Systèmes company and the global leader in creating end-to-end solutions to support the entire clinical trial process, today announced a collaboration with Oxford University Innovation’s Clinical Outcomes Team (OUI) to begin proactively adding OUI’s stable of clinical outcome assessments (COAs) into Medidata’s electronic COA (eCOA) Global Library. This significant collaboration will help accelerate clinical study start-up, support quality improvements, and drive study management efficiency. 

This agreement will give both Medidata and its customers access to questionnaires that are pre-configured, pre-approved, translated in multiple languages, and stored for future use. Author approved versions of these electronic patient reported outcome (ePRO) measures will be stored in Medidata’s eCOA library, ensuring easy use within future projects for both Medidata and OUI’s customers.

Minimizing the time required to properly deploy COA instruments (or questionnaires or surveys) within an eCOA study system is a key benefit for any clinical trial sponsor. This process has traditionally taken months, or even years, to ensure instrument developers (and sponsors) are confident in the precise reproduction of their work. This collaboration allows for the OUI portfolio of COAs regularly used by trial sponsors to be ready for trial deployment, following rigorous review and testing, straight out of the Medidata eCOA library. OUI’s questionnaires, including the Parkinson’s Disease Questionnaire (PDQ), the Endometriosis Health Profile (EHP), the Amyotrophic Lateral Sclerosis Questionnaire (ALSAQ), and the Oxford Participation and Activities Questionnaire (OxPAQ), are viewed as industry gold-standard instruments and are widely used. These have proven to effectively measure how a patient is feeling or functioning with a certain disease or condition. 

“This collaboration marks an important relationship with a prestigious partner and is another step forward to building our eCOA global library,” said Anthony Costello, senior vice president of mHealth at Medidata. “This joint project helps standardize these questionnaires and collate them on a unified digital platform, removing the need to build and reproduce the same questionnaire multiple times for different studies, customers, and regions.”

Medidata’s Rave eCOA is an easy-to-use, full-service offering that includes best-in-class technology, flexible deployment options, pre-validated global instrument library, professional services, and dedicated customer support. Medidata’s eCOA library - the first in the industry - now contains more than 200 forms and is being actively used to positively impact timelines and quality of ongoing studies. Medidata has seen hours of work reduced by more than 50 percent in some cases when using questionnaires from the eCOA library.

“We manage some of the most widely regarded and relied upon condition-specific COAs used by the pharmaceutical sector, which means we have a significant responsibility to ensure any electronic reproductions of our COAs are true to the validated original,” said David Churchman, Business Manager of Clinical Outcomes at Oxford University Innovation. “Collaborating with a trusted partner like Medidata to reliably deploy our well-known instruments is essential so that more companies can access and use our high quality questionnaires, and all stakeholders can have confidence in the end product.”

Medidata is a wholly owned subsidiary of Dassault Systèmes, which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization.

About Medidata

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. With over 20 years of groundbreaking technological innovation across more than 30,000 trials and 9 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and the largest patient-level historical clinical trial data set in the world. More than 1 million registered users across 2,100+ customers trust Medidata’s seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. The company is a wholly owned subsidiary of Dassault Systèmes (Euronext Paris: FR0014003TT8, DSY.PA), which with its 3DEXPERIENCE platform is positioned to lead the digital transformation of life sciences in the age of personalized medicine with the first end-to-end scientific and business platform, from research to commercialization. Medidata is headquartered in New York City and has been recognized as a Leader by Everest Group and IDC. Discover more at www.medidata.com and follow us @Medidata,

About Dassault Systèmes

Dassault Systèmes, the 3DEXPERIENCE® Company, is a catalyst for human progress. We provide business and people with collaborative virtual environments to imagine sustainable innovations. By creating virtual twin experiences of the real world with our 3DEXPERIENCE platform and applications, our customers can redefine the creation, production and life-cycle-management processes of their offer and thus have a meaningful impact to make the world more sustainable. The beauty of the Experience Economy is that it is a human-centered economy for the benefit of all – consumers, patients and citizens. Dassault Systèmes brings value to more than 300,000 customers of all sizes, in all industries, in more than 150 countries. For more information, visit https://www.3ds.com