ERT announced the integration of a wearable biosensor which captures and wirelessly transmits real-time, continuous and clinical-grade biometric measurements into the ERT electronic Clinical Outcome Assessment (eCOA) system. ERT will showcase a proof of concept demonstration of the integration at its Innovation Lab at the Drug Information Association (DIA) Annual Meeting, from June 14 to 17, in Washington, DC. ERT is a global provider of high-quality patient safety and efficacy endpoint data collection, cloud analytics and workflow solutions.
The ERT Innovation Lab capitalizes on the acceleration and diversification of technological advances for use in new medical product development and broad clinical care. DIA Annual Meeting attendees can visit the Innovation Lab to see demonstrations of progressive product advancements, including the biosensor patch and eCOA system integration, which are being developed to help pharmaceutical companies and CROs meet clinical trial objectives more efficiently and reliably.
“We are excited to have integrated a clinical grade wearable biosensor with our eCOA system to expand the exciting possibilities of collecting electronic patient data for clinical trials,” said Ron Sullivan, Executive VP, eCOA at ERT. “By demonstrating this integration at our Innovation Lab at the DIA Annual Meeting, we hope to show clinical researchers the ease and value of integrating important objective and subjective data to gain more comprehensive patient insight during clinical development.”
The biosensor is a disposable, wireless patch worn on the chest. The thin, light form factor is comfortable and discreet while providing healthcare professionals access to continuous vital sign data on their patients. The patch contains sensors and electronics, along with advanced algorithm technologies, to provide continuous, clinical-grade measurements of ECG, respiratory rate, heart rate, heart rate variability, skin temperature, physical activity, posture and fall detection.
As a proof of concept, ERT is capturing patient fall detection data from the patch biosensor and using it to trigger an episodic electronic diary assessment to capture information about the circumstance of the fall. Sponsors can use one or more of the vital statistics as needed to support efficacy and safety endpoints that meet their clinical development objectives.