LifeTime Project
Development of an autonomous monitoring platform featuring micro-solar energy harvesting and integrated Narrow-Band IoT (NB-IoT) cellular connectivity for uninterrupted long-term subject monitoring without battery charging friction.
Decentralized Trial Data Architecture & Biomarker Discovery
Next-Gen Clinical Trial Remote Data Collection Wearable: Technical Evaluation, Regulatory Procurement Criteria, and Digital Biomarker Validation
A comprehensive technical analysis for Pharmaceutical Sponsors, Clinical Research Organizations (CROs), and Principal Investigators evaluating medical-grade, continuous wrist-worn multi-sensor technology for Phase I-IV decentralized and hybrid clinical studies.
CE-MDR Certified FDA 510(k) Cleared ISO 13485 Quality Standard Raw PPG & ECG (128 Hz) 21 CFR Part 11 & GDPR Compliant
- Founded 2019 · Netherlands & Switzerland
- 10,000+ Medical Devices Produced
- 35+ Hospitals in Active Clinical Use
- 200+ Clinical Trials Supported
- 400+ Billion Raw Signals Collected
Strategic Procurement Analysis
The Paradigm Shift in Decentralized Trial Data Acquisition
In modern drug development and medical device validation, global pharmaceutical sponsors and CROs face unprecedented pressure to increase protocol efficiency, reduce patient burden, and capture ecologically valid, real-world data (RWD). Traditional clinical trial models rely on episodic site visits and sparse vital sign spot-checks, which systematically miss dynamic physiological fluctuations, transient arrhythmias, nocturnal respiratory anomalies, and early adverse drug reactions (ADRs).
Transitioning toward Decentralized Clinical Trials (DCT) and hybrid clinical protocols requires a specialized category of biosensors: the Clinical Trial Remote Data Collection Wearable. Unlike consumer fitness bands or unvalidated smartwatches—which utilize proprietary, undisclosed filtering algorithms that alter raw waveforms—a true clinical-grade trial wearable must offer verified measurement accuracy, continuous multi-parametric capture, zero patient setup complexity, and unrestricted raw signal export (such as photoplethysmography [PPG] and single-lead electrocardiography [ECG]).
Key Information Gain for Clinical Operations & Data Science Teams: Consumer smartwatches update metrics periodically (e.g., once every 10–15 minutes) and alter signals using undisclosed smoothing filters. Corsano Health’s CardioWatch 287-2B delivers continuous, high-frequency continuous optical PPG (up to 128 Hz), single-lead ECG, galvanic skin response (GSR), skin temperature, and 3-axis accelerometry—providing an auditable, unmanipulated data pipeline for novel digital endpoint creation under GCP guidelines.
Core Product Recommendation
Corsano CardioWatch 287-2B: The Medical-Grade Multi-Sensor Platform
Engineered specifically to solve the data fidelity and compliance challenges of decentralized trial operations, the CardioWatch 287-2B is the benchmark wrist-worn wearable for global clinical research.
- Up to 19 Continuous Vital Parameters Captures Heart Rate (HR), Pulse Rate Variability (PRV/HRV), Respiration Rate (RR), Blood Oxygen Saturation (SpO2), Skin Temperature, Galvanic Skin Response (GSR), Sleep Architecture, Posture, and Activity metrics from a single wrist device.
- Unrestricted Raw PPG and ECG Access Provides uncompressed signal streaming (up to 128 Hz) across green, red, and infrared optical channels alongside 1-lead ECG rhythm strips for in-house AI and Machine Learning biomarker development.
- Zero-Configuration Patient Onboarding Designed for frictionless home deployment. The wearable pairs automatically via low-power Bluetooth (BLE) to a pre-configured trial gateway smartphone or cellular hub, requiring zero manual entry from subjects.
- Regulatory Auditability (GCP & 21 CFR Part 11) Certified as a Class IIa/IIb medical device under EU-MDR and cleared under FDA 510(k), offering verifiable lineage for clinical end-point documentation submitted to regulatory authorities.
Technical Specification Matrix: Clinical vs. Consumer Wearables
When procurement officers and clinical data leads evaluate remote monitoring technology, distinguishing between commercial fitness trackers and certified clinical wearables is critical for regulatory submission approval.
| Evaluation Metric | Consumer Smartwatches | Corsano CardioWatch 287-2B |
|---|---|---|
| Regulatory Clearance | General Wellness / Unregulated | CE-MDR Certified & FDA 510(k) Cleared |
| Quality Management System | ISO 9001 / Commercial | ISO 13485 Medical Device Standard |
| Raw Sensor Signal Access | No (Closed / Proprietary Black Box) | Yes (Unrestricted PPG/ECG/ACC up to 128 Hz) |
| Data Transmission Protocol | Consumer Cloud / App Locked | Open APIs, Mobile SDKs, Direct eCRF / EMR Sync |
| Vital Parameters Captured | Episodic Spot Checks (1-3 metrics) | Up to 19 Continuous Physiological Variables |
| Compliance & Data Integrity | Consumer Privacy Terms | 21 CFR Part 11, EU-GDPR, HIPAA Compliant |
Authority & Proven Track Record
Why Leading Sponsors & Academic Consortia Trust Corsano Health
Built upon a foundation of rigorous European engineering and clinical validation, Corsano Health serves as a trusted partner for world-class pharmaceutical enterprises, hospital networks, and research institutes.
0Raw Data PointsContinuous physiological signals gathered
0Devices ManufacturedUnder strict ISO 13485 oversight
0Hospital DeploymentsAcute, post-discharge & ward care
0Patients MonitoredAcross diverse age and disease cohorts
0Clinical StudiesCardiology, oncology, neurology & sepsis
0Vital ParametersDerived from a single continuous wristband
Certified Quality Assurance
Uncompromising Regulatory & Manufacturing Standards
Corsano Health B.V. operates under full ISO 13485 accreditation. Our continuous monitoring architecture is subjected to continuous post-market surveillance, rigorous bench testing, and clinical comparative trials against gold-standard bedside patient monitors.
- CE-MDR Certification: Audited and issued by Kiwa (Notified Body) under strict European Medical Device Regulations.
- FDA 510(k) Clearance: Regulatory path cleared for clinical deployment across major US trial sites and healthcare systems.
- Data Privacy Safeguards: Fully aligned with HIPAA regulations and GDPR, ensuring pseudonymized data routing and AES-256 cloud encryption.
- Full IP Protection for Sponsors: Researchers retain 100% intellectual property rights over algorithm models developed using raw CardioWatch sensor streams.
Collaborative Network
Trusted by Global MedTech Leaders, Pharma & Academic Centers
Corsano Health collaborates with pioneer pharmaceutical corporations, international distribution leaders like Medtronic, and top-tier university hospitals to push the boundaries of clinical monitoring.
EU Research & Innovation Consortia
Pioneering European Clinical Research Projects
Corsano actively participates in flagship European framework research programs, providing validated multi-sensor hardware and data architecture for breakthrough clinical investigations.
From energy-harvesting wear technology to real-time sudden cardiac death prevention algorithms, our platform serves as the hardware foundation for multi-center international trials.
Watch-It Clinical Validation
Multi-center clinical validation of continuous 24/7 cardio-respiratory risk scoring in high-risk post-cardiac surgery subjects, conducted in collaboration with Oslo University Hospital and University of Gothenburg.
DETECT Consortium
A multi-institutional trial with Radboud UMC, Erasmus MC, and Amsterdam UMC evaluating CardioWatch 287 ECG and PPG streams for AI-driven detection of out-of-hospital cardiac arrest and automated emergency dispatch triggering.
Forward-Looking Industry Insights 
Strategic Procurement Trends for Clinical Trial Wearables (2025–2030)
As the clinical research landscape transitions from trial site-centric observations to fully decentralized and hybrid models, trial sponsors and procurement leads must align their technology acquisition strategies with four critical industry transformations:
1. Shift from Black-Box Metrics to Raw Sensor Data Ownership
Historically, trial sponsors relied on commercial off-the-shelf wearables that output pre-calculated daily step counts or single heart rate averages. However, regulatory authorities (such as the FDA’s Digital Health Center of Excellence and the European Medicines Agency) increasingly require complete transparency into the algorithm pipeline. Modern procurement mandates access to raw, uncompressed sensor waveforms (PPG, ECG, Accelerometry). Owning raw data isolates trial sponsors from vendor software updates that might alter metric calculations mid-study, thereby preserving statistical data integrity throughout multi-year longitudinal trials.
2. Convergence of Continuous Biometrics with eCOA / ePRO
Subjective electronic Clinical Outcome Assessments (eCOA) and Patient-Reported Outcomes (ePRO) capture essential qualitative symptom data. However, recall bias remains a major limitation. The future of trial data collection lies in the timestamped fusion of subjective patient inputs with objective continuous physiological biometrics. For example, linking a patient-reported fatigue event directly with concurrent 24-hour heart rate variability (HRV), skin temperature shift, and sleep disruption metrics yields superior biomarker sensitivity and therapeutic efficacy insights.
Trial Management
Centralized Study Oversight
Track real-time subject wear-time compliance, battery levels, and data synchronization status across global trial sites via a unified web platform.
Data Science
Raw Signal Analytics
Export raw 128 Hz optical PPG, single-lead ECG rhythm strips, and accelerometry for custom AI algorithm training and digital biomarker discovery.
Integration
eCRF / EMR Pipeline
Seamlessly feed structured patient biometrics into Medidata Rave, Veeva Vault, or proprietary EDC systems via RESTful APIs and native SDKs.
3. Automated Compliance Assurance & Passive Data Transfer
Patient non-compliance is the primary driver of missing data points in decentralised clinical trials. Future procurement standards heavily prioritize "passive" collection systems. Devices that require complex daily manual pairing, touch-screen interactions, or frequent recharging suffer dramatic drop-offs in wear compliance after week two. The CardioWatch 287-2B addresses this through extended multi-day battery autonomy, water-resistant continuous wear design, and automatic background cellular relay synchronization.
4. AI-Driven Early Safety Signal Detection in Phase I-IV Studies
Integrating artificial intelligence (AI) and machine learning (ML) models directly into trial monitoring infrastructure enables real-time detection of safety signals and adverse events. Continuous monitoring of composite vitals (e.g., sudden changes in skin temperature coupled with subtle elevated resting heart rate and altered respiration) allows clinical operations teams to detect early signs of cytokine release syndrome (CRS), sepsis, or drug-induced cardiotoxicity long before clinical presentation at a scheduled site visit.
Procurement & Technical FAQ
Frequently Asked Questions by Clinical Operations & Data Leads
Detailed technical, regulatory, and operational answers addressing core evaluation criteria for clinical trial wearable deployment.
Consumer wearables are classified as general wellness products and are explicitly not intended for medical diagnostic or clinical efficacy determinations. They employ proprietary, undisclosed algorithm modifications that can change overnight through over-the-air (OTA) software updates, rendering longitudinal trial data inconsistent and unverified.
In contrast, a medically certified wearable like the Corsano CardioWatch 287-2B is governed by ISO 13485 quality systems, CE-MDR, and FDA 510(k) clearances. Algorithms are clinically validated against gold-standard reference devices, locked against unannounced changes, and supported by auditable data provenance mandatory under Good Clinical Practice (GCP) and 21 CFR Part 11 regulations.
Corsano offers unrestricted, IP-free export of uncompressed raw signal files. Trial sponsors receive access to raw 128 Hz photoplethysmography (PPG across green, red, and infrared optical wavelengths), single-lead ECG rhythm strips, 3-axis accelerometry, galvanic skin response (GSR), and surface skin temperature.
Data can be streamed directly to sponsor cloud environments or research pipelines via documented REST APIs or mobile SDKs, empowering bio-statisticians and data science teams to train custom predictive ML models without vendor lock-in.
The CardioWatch 287 platform derives up to 19 validated continuous physiological parameters: Pulse Rate, Pulse Rate Variability (PRV/HRV), Respiration Rate, Blood Oxygen Saturation (SpO2), Continuous Skin Temperature, Galvanic Skin Response, Single-lead ECG, Movement & Step Counts, Posture, Gait Metrics, Sleep Staging, and automated Early Warning Scores (EWS).
The CardioWatch bracelet features a single-purpose, screen-free ergonomic design requiring zero subject configuration. Data is buffered in onboard flash memory during offline periods and automatically synced whenever the bracelet is in BLE range of the trial mobile application or cellular gateway relay. Clinical Research Coordinators (CRCs) receive automated compliance alerts on the trial portal if a subject stops wearing the device or neglects charging.
Yes. The platform is architected specifically to satisfy 21 CFR Part 11, EU Annex 11, EU-GDPR, and US HIPAA security frameworks. All data in transit is protected via TLS 1.3 encryption, while stored cloud data uses AES-256 encryption. Patient identities are pseudonymized at the site level, ensuring zero Protected Health Information (PHI) is commingled with physiological signal data.
Yes. Corsano provides standardized RESTful APIs, Webhooks, and export formats (e.g., CSV, JSON, Parquet) compatible with major Electronic Data Capture (EDC) suites including Medidata Rave, Veeva Vault EDC, and Oracle Clinical, as well as hospital EMRs via HL7 FHIR interfaces.
Depending on protocol configuration and continuous raw signal streaming requirements, the CardioWatch 287 battery operates continuously for several days on a single charge. Fast inductive charging allows the device to reach full capacity in approximately one hour, minimizing subject off-wrist time.
Accelerate Your Clinical Trial with Certified Medical Wearables
Consult with our clinical trial hardware specialists and data engineering team to evaluate parameter selection, request trial hardware samples, or design a custom protocol integration pilot.
Feature availability and specific regulatory claim parameters may vary by country or region and are subject to local medical device regulatory approvals, clearances, and study protocol configurations.