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genae INTEGR8 study embeds wearables in digital health data workflow

genae, a global contract research organization (CRO) and services provider for the medical device industry, has completed enrollment for the INTEGR8 study, a program to demonstrate and validate the integration of a wearable device (Microsoft Band, Microsoft) in an electronic data capture workflow (edc2go, genae).

For the duration of one month, the INTEGR8 study enrolled 19 subjects across 4 countries who answered quality of life questions via a wearable device.

The questions were sent from edc2go, a disruptive Electronic Data Capture (EDC) platform, to the subjects. The answers were transmitted to a smart phone via a Bluetooth connection and from there over an encrypted 3G/Wi-Fi connection to edc2go for storage and processing.

"This is an important step towards reducing costs by limiting follow-up visits, simplifying the clinical study and routine follow-up workflow, and enabling real-time assessment of the patient’s safety," said Bart Segers, CEO of genae.

"Although the technology is in an early phase, it is very promising and attracts a lot of attention from the stakeholders in the digital health data industries."

"From an investigator’s perspective, the integration of this wearable technology in data collection workflows may have a positive impact on patient compliance and medical costs," commented Dr. Stefan Verheye.

"Adherence to medication schedules, QOL indicators and pain scores are metrics that are captured today during telephone calls or follow-up visits. This technology may truly enable remote monitoring and ultimately improve patient outcome."

genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice.