Bridge the gap between raw biophysical signals and regulatory-grade clinical evidence. Powered by CE-MDR certified and FDA 510(k) cleared CardioWatch 287 multi-sensor hardware, offering IP-free 128 Hz raw waveform data for decentralised clinical trials (DCTs) and novel digital endpoint discovery.
In modern clinical drug development, reliance on episodic, in-clinic spot checks represents a fundamental bottleneck. Traditional Phase I–IV trials capture less than 0.1% of a patient's longitudinal physiological trajectory, leaving significant gaps during out-of-hospital periods. This lack of continuous data creates critical blind spots for pharmaceutical sponsors, clinical research organizations (CROs), and biostatisticians attempting to capture drug efficacy, subtle adverse events, and disease progression.
The emergence of the Pharmaceutical Digital Biomarker Platform solves this challenge by converting high-frequency biometric data into validated, objective digital endpoints. By capturing continuous photoplethysmography (PPG), single-lead electrocardiogram (ECG), tri-axial accelerometry, galvanic skin response (GSR), and skin temperature, biopharma research teams can extract actionable intelligence—ranging from autonomic nervous system modulation to sub-clinical hemodynamic shifts.
Unlike consumer-grade fitness trackers that rely on proprietary, closed-box algorithms, an enterprise-grade digital biomarker platform must deliver total algorithmic transparency. Corsano Health provides complete, unencrypted access to raw sensor waveforms sampled at up to 128 Hz. This enables data science teams to build custom predictive machine learning (ML) models, establish novel surrogate endpoints, and support regulatory submissions without IP lock-in.
A complete, medically certified end-to-end architecture bridging medical-grade wearable hardware, encrypted mobile gateway SDKs, and a GCP-compliant cloud analytics framework.
Engineered under ISO 13485 for long-term clinical compliance. Features water resistance, multi-day battery life, and passive patient operation.
Export IP-free raw biophysical signals directly into Python, R, or AWS/Azure ML infrastructure for custom digital biomarker development.
Manage multi-site global trials, track subject compliance, push OTA firmware updates, and manage secure data pipelines with role-based governance.
As global pharmaceutical companies transition from exploratory wearable pilots to fully integrated Phase II/III pivotal trials, procurement criteria are undergoing a fundamental transformation. Procurement leaders, clinical operation heads, and Chief Digital Officers are moving away from ad-hoc consumer wearables toward standardized, enterprise-grade biomarker infrastructure. Below are the five dominant procurement trends shaping the industry:
Historically, pharma sponsors utilized consumer smartwatches that provided aggregate daily metrics (e.g., average heart rate or estimated sleep hours). However, regulators such as the FDA and EMA require full traceabilty and verification of digital measurement methodologies. Procurement teams now mandate vendor contracts that guarantee raw signal access (unfiltered PPG, ECG, and accelerometry). Access to raw signals at 128 Hz ensures that algorithms can be re-analyzed historically if analytical pipelines evolve over a multi-year trial lifetime.
Regulatory authorities are scrutinizing data origin in clinical trials. Data originating from non-regulated consumer wearables faces significant challenges during NDA (New Drug Application) or BLA (Biologics License Application) reviews. Procurement mandates now demand verified Class IIa CE-MDR certification under EU Regulation 2017/745 and FDA 510(k) clearances. Medically certified hardware guarantees validated sensor accuracy, bio-compatibility, and rigorous post-market surveillance protocols.
Isolated data silos are no longer acceptable. Modern procurement processes prioritize digital biomarker platforms that offer turn-key integrations into Electronic Data Capture (EDC) systems such as Medidata Rave, Veeva Vault, and Oracle Health Sciences. Furthermore, APIs must support streaming data directly into cloud analytics platforms (AWS HealthOmics, Azure Health Data Services) to power real-time AI and synthetic control arm (SCA) modeling.
Patient drop-out remains one of the largest costs in clinical trials. Procurement evaluation teams rigorously evaluate device ergonomics, battery performance, and operational simplicity. Wearables requiring frequent charging, manual Bluetooth pairing, or complex patient inputs experience steep drop-offs in patient compliance. Wrist-worn form factors with passive continuous data collection and multi-day battery life ensure subject compliance rates exceeding 90% over extended trial durations.
With clinical trials spanning North America, Europe, and Asia-Pacific, procurement teams require strict compliance with regional data sovereignty frameworks, including EU GDPR, US HIPAA, and China Human Genetic Resources (HGR) regulations. Enterprise biomarker platforms must implement robust pseudonymization, encrypted end-to-end data transit (TLS 1.3), and zero-trust cloud architectures.
The convergence of advanced bio-sensors, microelectronics, edge computing, and artificial intelligence is unlocking brand-new categories of physiological endpoints. The pharmaceutical industry is currently experiencing three key technological paradigms:
Machine learning algorithms trained on continuous PPG and ECG signals can now detect sub-clinical autonomic degradation, early cardiovascular toxicity, and nocturnal respiratory instability long before physical symptoms manifest.
In immuno-oncology trials (e.g., CAR-T therapies), continuous skin temperature and heart rate variability tracking enable automated early warning alerts for Cytokine Release Syndrome (CRS) and systemic infection onset.
Next-generation research projects, such as Eurostars LifeTime, are pioneering ambient light energy harvesting microchips combined with direct NB-IoT connectivity to eliminate gateway dependencies entirely.
Addressing critical queries regarding data ownership, regulatory validation, AI algorithm training, and global trial deployment.
Corsano Health operates under a strict IP-open paradigm for pharmaceutical sponsors. When you utilize our Pharmaceutical Digital Biomarker Platform, your organization retains 100% intellectual property ownership over all proprietary features, biomarkers, and machine learning models developed using the exported raw data. Corsano provides the certified sensor hardware, infrastructure, and raw signal streams without demanding residual IP rights over your study-derived biomarkers.
All raw signal data streams (128 Hz optical PPG, single-lead ECG rhythm strips, 3-axis accelerometer, GSR, and skin temperature) are exported in open, non-proprietary formats (such as CSV, JSON, or Parquet) for seamless ingestion into your internal data science pipelines.
The Corsano CardioWatch 287-2B is certified as a Class IIa Medical Device under the European Union Medical Device Regulation (EU-MDR 2017/745), audited and verified by notified body Kiwa (CE 1984). In the United States, the platform has received FDA 510(k) clearance.
Manufactured under ISO 13485 quality management standards, the device is suitable for primary, secondary, and exploratory clinical trial endpoints in Phase I–IV pharmaceutical studies across Europe, North America, and participating global trial sites.
Yes. Corsano provides cloud RESTful APIs, Webhooks, and native mobile software development kits (SDKs for iOS and Android). Data can be configured to stream continuously or batch-synced from patient devices to the Corsano Cloud infrastructure, which can then automatically route pseudonymized raw biophysical data into your sponsor-controlled AWS, Google Cloud, or Microsoft Azure data lakes.
Episodic spot-checks rely on brief snapshots taken in clinical settings, capturing acute anxiety or artificial baseline shifts ("white coat effect") while missing diurnal rhythms and intermittent events. Continuous monitoring with CardioWatch 287 captures over 100,000 data points per patient per day. This provides statistical power to detect transient arrhythmias, subtle autonomic shifts, night-time respiratory instability, and early drug toxicity with significantly smaller sample sizes.
The Corsano Cloud infrastructure is built in accordance with GAMP 5 and Good Clinical Practice (GCP) guidelines. Data is end-to-end encrypted both in transit (TLS 1.3) and at rest (AES-256). The platform features comprehensive audit trails, role-based access management (RBAC), electronic signatures, and strict pseudonymization protocols compliant with 21 CFR Part 11, HIPAA, and EU GDPR standards.
Out of the box, the platform derives up to 19 validated parameters, including Heart Rate (HR), Inter-Beat-Interval (IBI), Heart Rate Variability (HRV - SDNN, RMSSD, LF/HF), Respiration Rate, SpO2 (O2 Saturation), Skin Temperature, Activity levels, Step Counts, Posture, Sleep Staging, and automated Early Warning Scores (EWS). Simultaneously, researchers can pull raw 128Hz multi-spectral PPG, single-lead ECG waveforms, and tri-axial accelerometer raw signals for custom feature extraction.
Patient adherence is optimized through a sleek, unobtrusive design weighing under 30 grams, featuring a single-purpose passive interface with no distracting screens or buttons. The device features extended battery life, robust water resistance, and background Bluetooth syncing via companion smartphone gateways or dedicated hub stations, yielding patient compliance rates exceeding 90% in long-term studies.
Yes. Corsano's open software integration framework is designed for rapid integration with major Electronic Data Capture (EDC) systems (such as Medidata, Veeva, Oracle) and eCOA platforms. Objective sensor telemetry and subjective questionnaire responses can be harmonized under unified subject IDs to analyze biophysical responses alongside patient-reported outcomes.
Extensive deployment experience across academic medical centers, clinical research consortia, and MedTech distributors worldwide.
Regulatory status determines whether digital biomarker data can support secondary or primary endpoints in NDA submissions. Corsano operates under audited medical device quality management systems.
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 the DETECT consortium, our collaboration with Corsano has been instrumental in advancing technological solutions aimed at the early detection of cardiac arrest. This partnership is paving the way for significant breakthroughs that we believe will greatly enhance patient care and outcomes.
CardioWatch offers automated vital signs monitoring and integrates data into health records, easing our nursing staff’s workload. Our hospital effectively addressed implementation areas like data security and legalities. We’re very pleased with our Corsano partnership.
Corsano actively participates in major European Horizon 2020, Eurostars, and national research initiatives. Our CardioWatch technology is deployed across clinical trials exploring early cardiovascular collapse, oncology side-effect monitoring, and continuous metabolic assessment.
Our dedicated medical data science team assists pharmaceutical partners with study protocol configuration, digital endpoint selection, and biostatistical dataset structuring.
Explore Scientific Publications
Developing an autonomous biophysical monitoring module combining energy-harvesting microchips with direct Narrow-Band IoT (NB-IoT) cellular connectivity for seamless long-term patient tracking.
Multicenter clinical validation of 24/7 continuous cardio-respiratory risk tracking in high-risk patients alongside Oslo University Hospital and the University of Gothenburg.
Pioneering early wearable-based detection of cardiac arrest and circulatory collapse in partnership with Radboudumc, Erasmus MC, and Amsterdam UMC.
Connect directly with our clinical deployment specialists and data engineering leads to review parameter access, sample data sets, API documentation, and trial pilot pricing.
Regulatory statement: CardioWatch 287 feature availability, specific biometric parameters, and regulatory claims vary by geographic region depending on local clearance status (CE-MDR, FDA 510(k)). Consult with our regulatory team for site-specific trial compliance guidelines.
