NEW YORK--(BUSINESS WIRE)--Medidata, the leading global provider of cloud-based solutions for clinical research in life sciences, is pleased to announce that its work on a joint mobile health (mHealth) initiative with GSK, one of the world’s leading research-based pharmaceutical and healthcare companies, was recognized as the 2016 “Clinical Partnership of the Year” at the inaugural Clinical and Research Excellence (CARE) Awards.
Medidata and GSK’s joint method development project evaluated the impact of unifying mHealth devices with cloud-based technologies in a clinical trial setting. The collaboration pioneered a method that has the potential to transform drug development, resulting in more efficient trials, the identification of “digital biomarkers” and better insight into treatment effectiveness and patient health.
“We believe this kind of technology can help us better understand patient responses to medicines and more closely meet patient needs without increasing the burden on those who participate in clinical trials,” said Julian Jenkins, GSK’s Vice President of Innovation, Performance and Technology in R&D.
Hosted by Informa’s Pharma Intelligence—the world’s leading provider of clinical and research intelligence and analysis, and home of leading brands such as Scrip Intelligence, In Vivo and the Pink Sheet—the CARE Awards celebrate excellence and innovation in the biopharmaceutical industry and a continued commitment to improving healthcare worldwide. A panel of judges, comprised of independent, senior industry experts from around the world, presented the top honor to Medidata and GSK at the April 27th awards ceremony in Boston.
In gathering 18 million data points on activity and vital signs per participant, per day, Medidata and GSK demonstrated that mHealth technologies have the power to comprehensively collect large volumes of objective data that is reliable, secure and analysis-ready, and provides real-time, continuous insight into patients’ physical status.
“Our collaborative project with GSK evolved from a shared perspective on how mHealth technology can fundamentally transform the way we conduct clinical research—enhancing patient engagement and accelerating the pace of innovation in drug development,” said Mike Capone, Medidata’s chief operating officer. “By integrating mobile health devices with the Medidata Clinical Cloud, we’ve proven that the technology exists today to successfully instrument patients, collect objective, high-quality information and tap into rich, new data sets, all in a safe, effective way.”
Medidata and GSK provided project participants with two wearable devices. Vital Connect’s HealthPatch® MD and ActiGraph’s wGT3X-BT Monitor continuously measured vital signs, electrocardiogram (ECG) data and activity levels. In addition, participants used Medidata Patient Cloud ePRO (electronic patient-reported outcomes), a mobile app for patient-reported outcomes offered as part of Medidata’s industry-leading technology platform. The participants carried smartphones that captured data from the mHealth devices, pulled this data into the Medidata Clinical Cloud® platform and then mapped it to the clinical record. Participants were asked to go about their standard daily routine and checked in with GSK’s Human Performance Lab only at the start and end of the effort.
Capone added: “As we continue to work with GSK to derive meaningful insights from the data, we envision a future in which mHealth studies will be standard of practice and clinical trials will be faster, less expensive and more patient-centric. We’re proud to accept this industry award from Informa as we lay the groundwork for life sciences companies to explore the exciting possibilities of mHealth—including better decision-making, better trial outcomes, and, ultimately, better therapies for patients.”
In addition to winning Clinical Partnership of the Year, Medidata was recognized as a finalist in the “Best Patient-Focused Technological Development” category for MOVE. In this behavioral study, Medidata tested whether mHealth tools could be used to drive better health outcomes in overweight adults with Type-2 diabetes. The pilot open-label clinical trial is part of Medidata’s ongoing efforts to work through the operational, technical and regulatory implications of incorporating mHealth devices and tools into clinical trials and, ultimately, facilitate a new model for drug development that aligns patient needs with faster study execution and reduced costs.
Connect with Medidata
- Read our blog, Geeks Talk Clinical
- Tweet this: .@Medidata & @GSKUS win #Clinical Partnership of the Year at @CARE_Awards for its joint #mHealth initiative: http://ow.ly/4n7gka #tech
- Follow us on Twitter: @Medidata
- Find us on LinkedIn
About Medidata
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. We are committed to advancing the competitive and scientific goals of our life sciences customers worldwide: more than 600 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations. Our industry-leading technology platform, the Medidata Clinical Cloud®, is the primary technology solution powering clinical trials for 17 of the world's top 25 global pharmaceutical companies, bringing new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting.
