Pharmaceutical sponsors and Contract Research Organizations (CROs) partner with Corsano Health to replace subjective self-reporting and intermittent site checks with continuous, validated biometric monitoring in Phase 1 through Phase 3 clinical trials.
The CardioWatch 287 medical smart bracelet records uninterrupted real-world physiological signals. By capturing continuous vital parameter trajectories rather than episodic snapshots during site visits, pharmaceutical research teams gain unprecedented visibility into drug safety, therapeutic efficacy, and patient treatment adherence.
Continuous monitoring significantly reduces protocol deviations, minimizes patient burden by eliminating unnecessary clinic visits, and yields high-fidelity digital endpoints for global clinical studies.
From early-stage safety profiling to post-market real-world evidence, Corsano provides the precision data pipeline required by life sciences sponsors.
Monitor high-risk drug candidates for cardiovascular and respiratory side effects with continuous single-lead ECG rhythm strip capture and multi-wavelength PPG signal processing.
Enable hybrid and decentralized clinical trials (DCTs). Trial participants remain comfortably monitored at home, accelerating recruitment and improving long-term retention.
Discover and validate novel digital biomarkers for complex diseases, oncology treatments, heart failure, sepsis, and neurological disorders using uncompressed raw data access.
Seamlessly connect biometric streams into your proprietary Electronic Data Capture (EDC) systems, centralized research databases, or custom clinical trial applications.
Corsano provides robust REST APIs and native iOS/Android SDKs that enable life sciences teams to ingest raw and derived parameter streams directly into existing trial infrastructure. Real-time data transfer eliminates manual data processing delays and lowers the risk of missing endpoints.
Enhance study protocol adherence and patient engagement with study-branded mobile applications. Custom app features include patient reminders, study notifications, eCOA questionnaires, and integrated medication tracking—building trial sponsor brand trust while giving participants clear visibility into their trial journey.
Built under strict European and global regulatory oversight to ensure study data is fully auditable and acceptable for regulatory submissions.
| Category | Specification & Standard |
|---|---|
| Regulatory Status | CE-MDR Certified (Class IIa/IIb), FDA 510(k) Cleared, ISO 13485 Manufacturing Quality Management |
| Sensors Integrated | 3-Axis Accelerometer, Optical PPG (Green, Red, Infrared), Single-lead ECG, Core Skin Temperature, Galvanic Skin Response (GSR) |
| Monitored Parameters | Up to 19 parameters: Heart Rate, HRV, Respiration Rate, SpO2, Skin Temperature, Pulse Wave Transit Time, Posture, Sleep Architecture, Activity Metrics |
| Raw Signal Export | IP-free raw accelerometer, PPG, ECG waveform, GSR, and temperature streams sampled up to 128 Hz |
| Data Protection | HIPAA & GDPR Compliant Cloud Architecture, End-to-End Encryption, Role-Based Access Controls |
| Device Form Factor | IP67/68 Water-resistant medical wristband, continuous battery operation, lightweight ergonomic casing for 24/7 wearability |
Unlike commercial fitness trackers, Corsano CardioWatch 287 is manufactured under ISO 13485 standards and holds formal CE-MDR certification and FDA 510(k) clearance. Its algorithms are clinically validated against gold-standard hospital reference devices, guaranteeing that physiological data is legally valid, compliant, and auditable for submission to regulatory agencies such as the FDA and EMA.
Yes. Corsano provides complete, IP-free access to raw multi-sensor data streams (PPG, ECG, Accelerometer, GSR, Temperature) up to 128 Hz. Pharmaceutical research teams can build, test, and patent their proprietary digital biomarkers and machine-learning predictive algorithms without algorithm lock-in or vendor royalty restrictions.
All data processing complies strictly with European GDPR and US HIPAA frameworks. The platform supports anonymized participant IDs, role-based data partitioning, and end-to-end data encryption in transit and at rest. Study administrators retain granular authority over data access and export permissions.
Yes. Corsano collaborates with global Contract Research Organizations (CROs) and pharmaceutical sponsors to support multi-center clinical trials worldwide, providing complete hardware provisioning, cloud portal setup, REST API ingestion pipelines, and dedicated data science support.
Connect with our clinical research and medical device specialists to discuss trial protocol design, regulatory availability, REST API integrations, and customized pilot deployments.
Feature availability and regulatory clearance status may vary by country or geographic region. Consult with Corsano Health regulatory representatives for local clinical trial compliance requirements.
