Medidata, a global provider of cloud-based solutions, announced the completion of a method development project conducted in  partnership with GlaxoSmithKline plc (GSK) to evaluate the impact of unifying  mobile health (mHealth) devices with cloud-based technologies in a clinical trialsetting. 

The collaborative project took place at GSK’s Human Performance Lab. They provided program participants with two  wearable devices to continuously measure vital signs, electrocardiogram (ECG) data and  activity levels. In addition, participants used Medidata Patient Cloud®, a mobile app  for patient-reported outcomes and they carried smartphones that captured  data from the mHealth devices, which then pulled this data into the Medidata Clinical Cloud®  and then mapped it to the clinical record.

The program 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 the well being of patients. All of the data  collected was audited and is compliant with FDA regulations. Additionally, the effort  indicated that mobile devices can support the long-term goal 

Medidata intends to use the technology infrastructure developed for this initiative as a model to enable new  Phase I–IV mHealth clinical trials, which the company will be supporting for clients  over the coming months.

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Medidata announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc