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”.
The results of the novel INTEGR8 study and technology will be published later this year. For further information, please visit www.genae.com.
genae is involved in the development and commercialization of medical devices, biologics and therapies that change medical practice. As a full service CRO and innovative services provider for the medical industries, genae aims at improving health and quality of life by innovating and accelerating high quality research. genae's Quality Management System is ISO 9001 compliant, has been tested rigorously and continues to pass regulatory and sponsor’s audits and inspections.
genae associates nv is a privately held company with principal offices in Antwerp, Belgium and is part of the genae group, the medical device CRO.
genae associates nv
Bart Segers, CEO
+32 475 566 780
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).