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Alliance to Collect Mobile Health Data for Clinical Trials

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(JEShoots, Pixabay)

21 July 2015. A partnership between health technology companies developing cloud-based solutions aims to make it easier to collect data from a wide range of mobile apps for clinical studies. Financial aspects of the agreement between digital health platform company Validic and clinical research technology company Medidata were not disclosed.

Validic, in Durham, North Carolina, provides a platform for connecting data collected from patient remote monitoring systems, wellness apps, fitness equipment, mobile sensors, and wearable devices with their health care provider customers, such as hospitals and clinics, as well as insurance companies, fitness clubs, and pharmaceutical companies. The company says it provides customers with a single connection to data from this wide variety and large number of sources, collecting data from more than 175 different apps, devices, and remote systems and an estimated 160 million individual clients. Validic says its platform meets privacy and reliability standards set by regulatory agencies, e.g. FDA and HIPAA.

Medidata, based in New York City, through its Clinical Cloud service, offers an online system for design, planning, management, and reporting clinical trials. According to the company, its Patient Cloud, part of the overall Clinical Cloud system, can harness mobile data which reduces data collection errors from using paper forms and increase patient compliance in less complex studies. As a result, many trials can recruit fewer participants and reduce the time needed for data analysis and reporting.

Under the agreement, health and wellness information collected by systems and devices connected to the Validic platform will be made available to Medidata for clinical trials. Data from Validic will be mapped to the Medidata Clinical Cloud format, adding to traditional clinical trial data such as lab results, vital signs, and adverse events.

In a company statement, Medidata’s president Glen de Vries calls the agreement “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.”

In November 2014, Medidata and drug maker GlaxoSmithKline completed an evaluation of mobile health devices in clinical trials. The results, say the companies, show mobile technologies can securely capture large volumes of data with mobile devices and provide real-time insights into the health of trial participants. The data collected in the assessment were audited and found compliant with FDA regulations. In addition, the use of mobile data can reduce burdens on trial participants by streamlining routine procedures and reducing visits to trial sites.

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