Transforming Cancer Trial Safety, Cardiotoxicity Detection, and Digital Biomarker Discovery through Continuous Multi-Sensor Telemetry and Unrestricted Raw PPG/ECG Data Stream Access.
Traditional clinical trials in oncology rely on episodic, in-clinic measurements that capture less than 0.1% of a patient's physiological trajectory. Continuous medical-grade wearable sensors bridge this blind spot, capturing real-time toxicity, cardiotoxicity, neutropenic infection onset, and functional performance loss between hospital visits.
Modern oncology drug development—spanning novel Immunotherapies, Antibody-Drug Conjugates (ADCs), Targeted Kinase Inhibitors, and CAR-T Cell Therapies—demands unprecedented vigilance regarding adverse event (AE) detection and patient safety monitoring. Episodic vital-sign collection during bi-weekly or monthly clinic visits routinely fails to capture transient yet life-threatening toxicities such as drug-induced QTc prolongation, cytokine release syndrome (CRS) prodromes, silent arrhythmia, nocturnal fever spikes signaling febrile neutropenia, and severe autonomic dysfunction.
Furthermore, evaluating patient functional status has historically depended on subjective ECOG (Eastern Cooperative Oncology Group) or Karnofsky performance scores, assessed during brief, stress-inducing clinical encounters. The integration of an Oncology Clinical Trial Wearable Sensor platform provides objective, continuous, high-frequency physical activity, circadian rhythm stability, and vital sign monitoring in the patient’s natural living environment.
While consumer-grade wearables lack regulatory clearance and hide algorithm calculations inside proprietary "black boxes," medical-grade clinical trial wearables yield verified physiological metrics along with raw waveform access (PPG, ECG, Accelerometer, GSR, Skin Temperature). This enables data science teams to create proprietary digital biomarkers for oncology endpoints while ensuring total compliance with global regulatory mandates (FDA 21 CFR Part 11, EU MDR 2017/745, HIPAA, and GDPR).
Engineered specifically for complex clinical research environments, the CardioWatch 287 combines high-density continuous signal acquisition with an ultra-lightweight, patient-centric design validated across frail oncology populations.
The CardioWatch 287 integrates advanced optoelectronic, electrophysiological, thermal, and kinematic sensors into a single, IP67 water-resistant enclosure. Designed for high patient compliance, it captures up to 19 vital parameters continuously:
When selecting an Oncology Clinical Trial Wearable Sensor, biopharmaceutical sponsors and Contract Research Organizations (CROs) must carefully evaluate regulatory clearance, signal sampling capabilities, raw data accessibility, and battery endurance. Below is an objective technical comparison outlining why the Corsano platform serves as the gold standard for oncology trial infrastructure.
| Evaluation Criteria | Corsano CardioWatch 287 | Consumer Smartwatches | Single-Parameter Medical Patches |
|---|---|---|---|
| Regulatory Clearance | CE-MDR Certified, FDA 510(k) Cleared | General Wellness / Unregulated | Varies (Often FDA 510k only) |
| Measured Parameters | Up to 19 Parameters (ECG, PPG, Temp, GSR, SpO2, ACC) | Basic HR, Activity, Estimated Sleep | Single (e.g., ECG only or Temp only) |
| Raw Data Access | Unrestricted Raw Signals (128 Hz PPG, ECG, ACC, GSR) | No Raw Signal Access (Closed Ecosystem) | Limited or Proprietary Format |
| IP & Biomarker Rights | 100% Sponsor IP Ownership | Vendor Retains Data Rights | Vendor Algorithm Lock-in |
| Battery Endurance | Multi-day Continuous Telemetry | 18 - 24 Hours (Daily Charging) | 3 - 7 Days (Disposable / Non-rechargeable) |
| Patient Wearability & Adherence | Wrist-worn, Non-invasive, Highly Tolerated | High, but complex consumer UI distracts patients | Skin irritation from prolonged adhesive patch wear |
| System Integration | REST APIs, Mobile SDKs, EDC/EMR & eCOA compatible | Proprietary Cloud Sync Only | Custom Integration Required |
In cancer trials, relying solely on black-box proprietary algorithms introduces severe risks to endpoint validity. Corsano provides sponsors with direct access to raw PPG (green, red, infrared), raw single-lead ECG, raw accelerometry, skin temperature, and electrodermal activity sampled at 128 Hz. This unrestricted access allows sponsor data science teams to:
Founded in 2019 with headquarters in the Netherlands and Switzerland, Corsano Health has emerged as a premier medical wearable provider, backed by audited quality management systems, extensive peer-reviewed publications, and deployment across major hospital networks.
Corsano operates under an ISO 13485 certified quality management framework. Our devices carry formal CE-MDR certification (issued by notified body Kiwa) and FDA 510(k) clearances, ensuring data admissibility in primary trial endpoints.
Our RESTful APIs and iOS/Android SDKs enable smooth integration into existing Electronic Data Capture (EDC) systems, Electronic Clinical Outcome Assessment (eCOA) portals, and hospital Electronic Medical Records (EMRs).
Sponsors and CRO site monitors gain real-time visibility into subject compliance, device wear-time, battery status, and sensor operational health across multi-center global sites.
As oncology research transitions toward decentralized trials, targeted biotherapeutics, and AI-driven precision medicine, wearable procurement strategies are undergoing a fundamental transformation.
Novel therapeutic modalities such as Bispecific Antibodies and ADCs carry risk profiles including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), severe pulmonary toxicity, and delayed cardiotoxicity. Over the next five years, trial protocols will increasingly mandate 24/7 real-time physiological telemetry to detect early autonomic imbalance, subclinical temperature elevations, and subtle respiratory rate accelerations prior to fulminant clinical collapse.
Regulatory authorities including the FDA and EMA are emphasizing the need for objective, continuous functional assessments in cancer drug approvals. Continuous physical activity monitoring, gait velocity evaluation, and circadian rhythm disruption index (CRDI) derived from 128 Hz accelerometer streams are quickly replacing subjective ECOG scales. Biopharma sponsors procuring wearable sensors are prioritizing devices that provide raw kinematic data to build validated digital activity endpoints.
Oncology patients frequently experience severe fatigue, nausea, and cognitive distress resulting from heavy treatment regimens. Modern trial design prioritizes zero-burden patient interfaces: automated Bluetooth pairing, passive background data upload via cellular gateways, extended multi-day battery life, and comfortable, wrist-worn form factors that eliminate the need for manual patient logging or irritating skin patches.
Global sponsors are actively steering away from closed consumer wearable ecosystems. Procurement departments now demand strict data sovereignty terms: complete ownership of raw biometric data streams, documented open APIs, direct mobile SDK availability, and zero risk of algorithm modification mid-trial. Corsano Health’s open architecture meets these institutional requirements, ensuring longitudinal study integrity across multi-year oncology trials.
Addressing key technical, regulatory, and operational questions asked by global clinical trial procurement teams, CRO directors, and principal investigators.
While adhesive chest patches provide short-term continuous ECG, oncology trial participants frequently report severe skin irritation, contact dermatitis, and discomfort during prolonged protocols (especially those undergoing radiation therapy or experiencing chemo-induced skin fragility). The Corsano CardioWatch 287 wrist-worn smart bracelet offers exceptional long-term patient wearability, continuous multi-parameter telemetry (PPG, ECG, SpO2, Temperature, GSR, Accelerometer), and multi-week adherence without skin breakdown.
Chemotherapeutic agents (such as anthracyclines, fluorouracil, and HER2 inhibitors) can cause subclinical cardiac injury, QT interval prolongation, and microvascular stress long before symptomatic heart failure develops. Continuous photoplethysmography (PPG) tracks heart rate variability (HRV) decay and pulse wave velocity changes, while single-lead ECG rhythm strips capture arrhythmias and electrical conduction changes during ambient daily activities and sleep.
Yes. Unlike consumer wearables that restrict access to aggregated daily summaries, Corsano provides 100% sponsor data ownership with unrestricted export of raw PPG (3 wavelengths), single-lead ECG, 3-axis accelerometer, skin temperature, and GSR data sampled at up to 128 Hz via RESTful APIs, cloud pipelines, or raw CSV/JSON formats.
The Corsano platform architecture enforces strict separation of Patient Health Information (PHI) and pseudonymized physiological trial data. Fully compliant with EU GDPR and US HIPAA mandates, the system utilizes AES-256 encryption at rest and TLS 1.3 in transit. Data hosting locations can be configured within EU or US cloud regions according to sponsor protocol requirements.
To eliminate tech burden for frail or elderly patients, Corsano offers pre-configured cellular hub gateways. Patients simply plug the gateway into a wall outlet at home; the CardioWatch 287 bracelet automatically pairs via BLE and streams encrypted continuous vital signs to the cloud portal without requiring patient smartphone operation, manual pairing, or app navigation.
Corsano supplies complete regulatory dossiers for IRB/IEC submission, including CE-MDR certificates, FDA 510(k) clearance letters, ISO 13485 quality management documentation, clinical validation reports, Investigator's Brochure (IB) materials, cybersecurity assessment reports, and patient informed consent protocol documentation templates.
The CardioWatch 287 is optimized for continuous multi-sensor operation, offering multi-day battery endurance under full telemetry streaming modes. Fast magnetic charging allows patients to fully recharge the bracelet in under 90 minutes during routine hygiene breaks, minimizing missing data windows.
I’ve tried out more wearable sensors than most people, and the CW287-2B is by far my favorite and most valuable. Congratulations to your entire team for your vision and for delivering on that. I believe your technology will have a significant impact on improving health across the globe.
As part of our research consortia, our collaboration with Corsano has been instrumental in advancing continuous monitoring solutions aimed at early physiological deterioration detection. This technology is paving the way for breakthroughs in complex patient care.
CardioWatch offers automated vital signs monitoring and integrates data directly into clinical records, easing nursing staff burden while delivering reliable continuous patient tracking. We are extremely pleased with our Corsano partnership.
Corsano Health collaborates with pharmaceutical leaders, contract research organizations, and academic centers worldwide to advance wearable telemetry in decentralized trials.
Connect with our clinical study directors and biomedical engineering experts to discuss protocol design, regulatory submission packages, API/SDK documentation, and pilot device evaluation kits.
Feature availability and regulatory indications may vary by country or region and are subject to applicable regulatory approvals, clearances, and local medical device requirements.
