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Medidata announced the completion of a method development project conducted in partnership with GlaxoSmithKline plc
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.
Read the full release here.