Continuous Vital Signs Monitoring for Pharmaceutical Clinical Trials
Drug development demands continuous, objective, and reliable physiological data throughout the trial
lifecycle. Traditional approaches rely on episodic, site-based measurements that capture only snapshots
of a patient’s condition, missing critical inter-visit events and limiting the resolution of safety and efficacy
assessments. As regulatory agencies increasingly endorse digital endpoints and wearable-derived
biomarkers, pharmaceutical sponsors need a monitoring platform that is medically certified, clinically
validated, and practical for real-world, multi-site deployment.
Corsano’s CardioWatch 287 System addresses this need directly. It is a wrist-worn, medical-grade, multi-parameter monitoring system — CE-MDR certified (Class IIa) and FDA 510(k) cleared — that enables continuous, 24/7 collection of vital signs and raw sensor data in ambulatory, in-clinic, and home-based settings. The system has been deployed in over 200 clinical studies across cardiovascular, oncology, immunology, and stress-related therapeutic areas, making it one of the most extensively validated wearable platforms in pharmaceutical research.
Monitored Parameters
The CardioWatch 287 captures a comprehensive set of clinically relevant parameters from a single, lightweight (~15g) wrist-worn device, eliminating the need for multiple sensors, patches, or body-worn devices that increase participant burden and reduce compliance.
Continuously monitored parameters:
Heart rate (PPG and ECG derived), heart rate variability (RR intervals), respiratory rate (breaths per minute), peripheral oxygen saturation (SpO₂), cuffless non-invasive blood pressure (cNIBP), core body temperature (CBT), activity levels (steps, cadence, motion classification), sleep staging and duration, and galvanic skin response (GSR/EDA) for stress and autonomic assessment.
On-demand and supplementary parameters:
Single-lead ECG for arrhythmia confirmation, atrial fibrillation detection with AFib burden quantification, and non-invasive cuffless blood pressure. The system captures up to 19 vital parameters, configurable per study protocol.
Raw sensor data: Accelerometer (XYZ), PPG (Green, Red, Infrared channels), and ECG waveforms are available at sampling rates up to 128 Hz, enabling sponsors and research partners to develop proprietary algorithms and novel digital biomarkers from IP-free raw data.