Medidata lands mHealth stroke clinical trial deal with Chinese drug developer

China flag

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.

Infographic Download

Reducing Time to Clinic for Your Biomedical Applications

Gelatin methacryloyl (GelMA)-based biomaterials have been widely used in various biomedical research applications due to their suitable biological properties and tunable physical characteristics. Especially over the past 5 years, GelMA-oriented research and patent applications have been growing exponentially, and many of these research concepts are now being translated towards the clinic. Suitable GelMA biomaterials are therefore indispensable to keep pace with the newest medical innovations.

Download to learn more about the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments.

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.”

Suggested Articles

A few years ago, one of our Fierce editors met a Big Pharma R&D chief for the first time. “You’re the ones with the scary name,” he joked.

There's no evidence personal patient information leaked during the 11-week breach, but the same can't be said about Sangamo's own secrets.

Through a new online tracker, AllTrials names sponsors who fail to report clinical trial results on time per the FDAAA Final Rule.