Medidata lands mHealth stroke clinical trial deal with Chinese drug developer

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Medidata ($MDSO) has signed up to provide its cloud platform and mobile health capabilities to Techfields Pharma. Techfields will use the technologies to power a Phase II ischemic stroke study, in which the Chinese drug developer will use Garmin vivofit 3 activity trackers to monitor movement and mobility.

The choice of vivofit activity trackers is indicative of the central role Medidata is playing in the trial. Medidata entered into an alliance with Garmin last year, at which time it highlighted the year-long battery life of the vivofit activity trackers as making them well suited for clinical trials. By deploying vivofit devices, Techfields has cut the risk of participants comprising the comprehensiveness of the dataset by removing their trackers and forgetting to put them on again.

Medidata is handling the task of continuously capturing data from the devices using its SensorLink platform, giving Techfields the results it needs to assess how its stroke drug, TF0023, performs against the secondary endpoints of change in daily activity and sleep condition. SensorLink is designed to feed data into the Rave EDC system in a regulatory-compliant manner.

In this regard, as in several others, Medidata is both the glue that links the technologies together, and either a partner or provider of a the tools themselves. The eClinical juggernaut is providing Techfields with an app to capture electronic patient-reported outcomes on iPads. And all of the data is being pulled into the Medidata Clinical Cloud.

Techfields sees value in taking this tech-enabled approach to the clinical trial.

“Cloud and mobile health technologies offer new channels for maximizing the value of clinical data, and we believe they will play an increasingly important role in our ability to bring vital new medicines to patients,” Techfields President Chongxi Yu said in a statement.

“Using the Medidata platform, our research teams can more quickly access richer, more complete clinical datasets while gaining valuable insight into patient well-being and disease progression. This is a key focus of our R&D strategy.”