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Collaboration Enables Use of Actionable, Patient-Generated Data in Clinical Trials from Extensive Range of mHealth Sensors, Wearables and Apps
NEW YORK, N.Y. and Durham, N.C. – July 21, 2015 – Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, and Validic, the healthcare industry's leading digital health platform, today announced a collaboration to propel connectivity and innovation in clinical research by expanding access to patient-generated data from a broad range of consumer and medical grade mobile health (mHealth) devices and apps. By integrating Validic’s digital health platform with the Medidata Clinical Cloud®, Medidata and Validic are providing the technology infrastructure needed to transform clinical trials through the use of patient-generated data that is secure, regulatory-compliant and actionable.
The collaboration significantly increases the breadth of mHealth tools that can be used to support clinical research, giving trial sponsors greater flexibility to select sensors, wearables and apps based on specific study endpoints and patient needs. Data generated by the more than 175 devices and apps in the Validic ecosystem-including those from Garmin, Fitbit, Jawbone, Withings and others-can now be integrated into the Medidata platform. Once data is transferred through the secure, regulatory-compliant environments of Validic’s platform and the Medidata Clinical Cloud, patient data from the mHealth tools is then mapped to the clinical record and unified with traditional clinical measures.
“At Medidata, we recognize that the rapidly expanding ecosystem of mobile health technologies requires openness and interoperability,” said Glen de Vries, Medidata’s president. “Our partnership with Validic is a big step toward realizing the potential of mobile health in clinical research because it offers life sciences organizations the flexibility to select the mHealth tools that provide the most clinically meaningful information for specific patient populations. We’re excited to be working alongside a like-minded company that is using technology to transform the way stakeholders across the healthcare industry collaborate and innovate.”
Validic’s innovative, scalable and FDA Class I Medical Device Data System (MDDS) delivers standardized and HIPAA-compliant patient health data from best-in-class consumer and medical grade devices and apps. Medidata’s cloud-based infrastructure gathers patient data from these mHealth tools and integrates it with other traditional data collected in studies, including lab information, clinician-entered vital signs and adverse events. The Medidata platform is currently enabling top life sciences companies to conduct sophisticated Phase I–IV mHealth clinical trials worldwide.
“It is a great privilege to continue to grow our digital health ecosystem with Medidata, a company that has pioneered the use of innovative technology to transform clinical research and help bring important new therapies to patients across the globe," said Ryan Beckland, co-founder and CEO of Validic. “Through our complementary technology platforms, Validic and Medidata are making it possible for companies conducting clinical trials to easily and efficiently access mHealth data, and glean valuable insights that have the potential to significantly enhance patient engagement and improve patient outcomes.”