Medidata and Validic collaboration uses mhealth to transform clinical trials
July 29, 2015
A collaboration between Medidata and Validic aims to propel connectivity and innovation in clinical research by expanding access to patient-generated data from a broad range of consumer and medical grade mhealth devices and apps.
By integrating Validic’s digital health platform with the Medidata Clinical Cloud, the companies hope to provide the technology infrastructure needed to transform clinical trials through the use of patient-generated data that is secure, regulatory-compliant and actionable.
New York-based Medidata is a global provider of cloud-based systems for clinical research in life sciences.
The collaboration 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 and Withings – can be integrated into the Medidata platform.
Once data are transferred through the secure, regulatory-compliant environments of Validic’s platform and the Clinical Cloud, patient data from the mhealth tools are then mapped to the clinical record and unified with traditional clinical measures.
“We recognise 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 towards realising the potential of mobile health in clinical research because it offers life sciences organisations 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 scalable and FDA Class I medical device data system (MDDS) delivers standardised and HIPAA-compliant patient health data from consumer and medical grade devices and apps. Medidata’s cloud-based infrastructure gathers patient data from these mhealth tools and integrates them 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 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 North Carolina-based 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.”
Validic’s cloud-based, digital health platform provides convenient and quick access to patient data from in-home clinical devices, wearables and patient healthcare applications. By connecting its growing base of customers – that include providers, pharmaceutical companies, payers, wellness companies and health IT vendors – to the continuously expanding list of digital health technologies, it lets healthcare companies better coordinate care across their communities, improve their patient engagement strategies and more efficiently manage their patient populations.