Medidata Ushers in Era of Choice as Life Science Companies Can Now Conduct Both Virtual and On-site Clinical Trials on One eClinical Platform

Medidata (NASDAQ:MDSO) announced today that its virtual trials platform, Engage, is now being offered as a part of the Medidata Clinical Cloud®, providing researchers unmatched flexibility to conduct clinical trials virtually, on-site, or as a hybrid.

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Combining Engage functionality with the rest of Medidata’s uniquely unified platform enables new possibilities in trial design. By leveraging broad capabilities for both standard and virtual protocols, customers can use what Medidata calls the "Trial Dial” to choose the right balance of site-based visits and virtual visits best suited for achieving maximum study efficiency and data quality.

With a new emphasis on targeted therapies, traditional trials solely conducted at research centers are increasingly expensive and present new challenges, such as growing complexity of protocol designs, the explosion of available data points, and patient recruitment. Better patient engagement and more personalized study designs are becoming more and more desirable in clinical research. Virtual trial designs already implemented by Medidata have been shown to dramatically reduce or eliminate the need for ongoing site visits, allowing for research to be done at a huge cost savings to the sponsor and in a much more inclusive and convenient way for patients.

"Medidata remains the partner of choice to design modern approaches to clinical trials,” said Glen de Vries, co-founder and president of Medidata. "The ability to conduct combinations of virtual or onsite trials essentially creates a ‘Trial Dial’ to calibrate the optimal protocol for patients. This type of hybrid trial will play a central role in the future of clinical research. The use of our platform for large, ongoing virtual trials shows how the market is embracing this new paradigm.”

Engage, acquired in 2017 as part of the Mytrus acquisition, was implemented in the industry’s first fully virtual study under an IND (investigational new drug) application with Pfizer in 2011. Medidata is currently conducting a number of virtual studies on behalf of global pharmaceutical and biopharmaceutical companies, including the well-publicized aspirin study ADAPTABLE, which is the largest virtual trial ever conducted with an enrollment target of 15,000 patients. That study, sponsored by PCORI (Patient Centered Outcomes Research Institute), is intended to evaluate low dose versus high dose aspirin for patients with heart disease and is managed entirely on Medidata’s platform.

The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developers—from study design and planning through execution, management, and reporting.

With data from more than 4 million patients and over 14,000 clinical trials, and Medidata Rave® underpinning the entire platform, Medidata is the only eClinical provider that has both the technology and data to support virtual trials of all sizes.

About Medidata

Medidata's unified platform, pioneering analytics, and unrivaled expertise power the development of new therapies for over 1,000 pharmaceutical companies, biotech, medical device firms, academic medical centers and contract research organizations around the world. The Medidata Clinical Cloud® connects patients, physicians and life sciences professionals. Companies on the Medidata platform are individually and collaboratively reinventing the way research is done to create smarter, more precise treatments. For more information: www.mdsol.com

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