ERT, a global solutions provider for patient safety and efficacy endpoint data collection headquartered in Philadelphia, Pa., has integrated a wearable biosensor that captures and wirelessly transmits real-time, continuous, clinical-grade biometric measurements into the ERT electronic Clinical Outcome Assessment (eCOA) system.
The biosensor is a disposable, wireless patch worn on the chest. Its thin, light form factor is comfortable and discreet while providing healthcare professionals access to unprecedented amounts of 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/or safety endpoints that meet their clinical development objectives.