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Continuous Digital Biomarker Architecture

Next-Generation Electronic Clinical Outcome Assessment (eCOA) System: The Paradigm Shift Toward Continuous Sensor-Augmented Decentralised Clinical Trials

Bridging subjective patient-reported outcomes (ePRO) with high-fidelity continuous biosignal telemetry. Corsano Health presents an enterprise-grade Electronic Clinical Outcome Assessment (eCOA) System engineered for pharmaceutical sponsors, CROs, and clinical research institutions seeking regulatory compliance, zero data loss, and validated digital biomarkers.

CE-MDR Certified FDA 510(k) Cleared ISO 13485 Audited 21 CFR Part 11 Compliant Raw Signal Access (128 Hz)
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  • Founded 2019 · Netherlands & Switzerland
  • 10,000+ medical devices produced
  • 35+ global academic medical centres
  • 200+ decentralised clinical trials supported
  • Unrestricted raw telemetry export up to 128 Hz
Executive Summary & Market Dynamics

Reinventing eCOA: Why Standalone Questionnaires No Longer Satisfy Modern Clinical Endpoint Requirements

In contemporary pharmaceutical R&D, the traditional approach to an Electronic Clinical Outcome Assessment (eCOA) System relies heavily on episodic, self-reported patient surveys (ePRO) and periodic clinician scores (ClinRO). While valuable, episodic reporting suffers from recall bias, variable patient compliance, and a complete absence of physiological context between study visits.

As global CROs, trial sponsors, and regulatory agencies elevate their scrutiny under FDA 21 CFR Part 11 and EU GCP guidelines, clinical trial designs require an information gain advantage. Corsano Health redefines the Electronic Clinical Outcome Assessment (eCOA) System by pairing structured electronic questionnaires with continuous, medical-grade biotelemetry.

By continuously tracking up to 19 physiological parameters—including single-lead ECG rhythm strips, continuous photoplethysmography (PPG), respiration rate, skin temperature, and galvanic skin response (GSR)—the Corsano eCOA platform contextualizes subjective patient logs with objective clinical data. When a trial participant reports acute fatigue, dyspnea, or chest discomfort via an ePRO prompt, biostatisticians can immediately correlate the event against high-density raw physiological waveforms recorded moments prior.

Corsano eCOA System ecosystem featuring CardioWatch smart bracelet, gateway smartphone app, and unified research web dashboard
The Corsano unified eCOA ecosystem: Medical smart bracelet, participant gateway application, and cloud biostatistical portal.
Recommended Product Stack

Corsano Enterprise eCOA Product Architecture

A robust Electronic Clinical Outcome Assessment (eCOA) System requires seamless integration across physical sensors, participant user interfaces, secure data pipelines, and biostatistical analytics.

Corsano CardioWatch 287 medical smart bracelet for eCOA clinical trials
Medical Wearable Sensor

CardioWatch 287-2B Bracelet

The core sensor engine for objective outcome measurement. CE-MDR certified and FDA 510(k) cleared multi-sensor bracelet engineered for 24/7 continuous wearability in decentralized clinical trials.

  • PPG (Green, Red, IR) & Single-Lead ECG
  • Skin Temperature, Accelerometry & GSR
  • IP67 Waterproof & Multi-day Battery Autonomy
  • High-compliance ergonomic form factor
Corsano eCOA Mobile Gateway Application for ePRO and participant questionnaires
Participant Mobile Interface

Corsano eCOA Gateway & ePRO App

Validated patient-facing mobile software supporting customizable questionnaires, eDiaries, event-triggered prompts, and automated Bluetooth syncing of continuous biosignals.

  • FDA 21 CFR Part 11 compliant audit trails
  • Event-driven questionnaires based on vital spikes
  • Multilingual localization & voice-prompt support
  • Offline data storage with automatic cloud retry
Corsano eCOA Research Portal and Cloud Analytics Platform
Biostatistical Portal & API

eCOA Cloud Portal & Raw Telemetry API

A centralized research portal for investigator sites, biostatisticians, and CRO data managers. Provides real-time subject compliance tracking and open data extraction.

  • IP-Free raw waveform access up to 128 Hz
  • RESTful APIs & Mobile SDKs for EDC integration
  • Role-based encryption (GDPR / HIPAA ready)
  • Automated compliance alert logic

Comprehensive eCOA Modality Alignment

The Corsano Electronic Clinical Outcome Assessment (eCOA) System harmonizes all four recognized clinical outcome modalities into a unified, audit-ready data stream:

1. ePRO (Patient-Reported Outcomes): Daily symptom logs, quality-of-life (QoL) scale responses, and subjective pain scores.
2. ClinRO (Clinician-Reported Outcomes): Investigator visit ratings, severity index assessments, and structured diagnostic notes.
3. ObsRO (Observer-Reported Outcomes): Caregiver inputs for pediatric or cognitively impaired study cohorts.
4. PerfO (Performance Outcomes): Objective physical activity, gait analysis, nocturnal posture shifts, and continuous vital capacity derived from sensors.
Strategic Sourcing Analysis

Procurement directors and clinical operations executives at Tier-1 pharmaceutical companies are rapidly shifting their vendor selection criteria. Discover the key trends defining modern eCOA sourcing strategies.

1. Convergence of Continuous Physiological Telemetry and ePRO

Legacy eCOA systems relied on standalone smartphone apps or dedicated handheld tablets that collected survey data once or twice daily. Sourcing teams now demand multi-modal platforms where wearable sensors continuously record baseline biomarkers (Heart Rate Variability, SpO2, Respiratory Rate, Skin Temperature) alongside survey responses. This dual-layer approach eliminates missing data points and provides objective validation for drug efficacy endpoints.

2. Mandatory Access to Unrestricted Raw Sensor Waveforms (IP-Free Data)

Historically, medical wearable vendors locked raw data behind proprietary, black-box algorithms, supplying sponsors only with processed minute-by-minute averages. Modern procurement specifications explicitly mandate raw PPG, ECG, and accelerometer signal access sampled at 64 Hz to 128 Hz. Unrestricted raw waveform access allows pharmaceutical data science teams to train proprietary machine learning models and establish novel digital biomarkers without vendor lock-in.

3. Stringent Regulatory Harmonization (CE-MDR, FDA 510(k), and 21 CFR Part 11)

Procuring non-certified consumer devices for clinical trials introduces tremendous regulatory risk. Global trial sponsors require medical devices manufactured under ISO 13485 quality management systems with explicit CE-MDR certification in Europe and FDA 510(k) clearance in the United States. Furthermore, cloud databases must guarantee audit trails, cryptographic data security, and compliance with 21 CFR Part 11, Annex 11, HIPAA, and GDPR.

4. Device Reuse & Sustainability in Decentralised Clinical Trials (DCTs)

Single-use monitoring patches create substantial electronic waste and recurring procurement expenses across Phase II and Phase III trials. Procurement officers are actively transitioning toward durable, medical-grade smart bracelets like the CardioWatch 287-2B. Designed for easy sanitization, rapid provisioning, and high patient comfort, these multi-use wearables dramatically reduce cost-per-patient while meeting organizational ESG (Environmental, Social, and Governance) mandates.

Procurement Comparison Matrix: Legacy eCOA vs. Corsano Sensor-Augmented eCOA System

Evaluation Parameter Legacy Standalone eCOA Systems Corsano Next-Gen eCOA System
Data Modality Episodic survey responses (ePRO/ClinRO only) Hybrid continuous biotelemetry + ePRO / ClinRO / PerfO
Biomarker Validation Subjective, subject to recall bias and gaming Objective verification via raw PPG, ECG, SpO2, and temp telemetry
Raw Signal Export None (Aggregated output or proprietary black box) Full raw waveform export (up to 128 Hz raw PPG/ECG/ACC/GSR)
Regulatory Status Software-only or non-medical consumer wearables Medical Device Certified (CE-MDR, FDA 510(k), ISO 13485)
Participant Burden High manual survey frequency to catch symptom shifts Low (Passive continuous monitoring with event-driven prompts)
EDC Integration Manual CSV export or custom middleware connectors Native RESTful APIs, Mobile SDKs, and direct EMR/EDC pipelines

Equip Your Clinical Trial with Corsano's Certified eCOA Architecture

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Industry Foresight

How AI-driven predictive modeling, ambient sensing, and passive biometric verification are shaping the next decade of clinical outcome assessments.

1. Adaptive, AI-Triggered Survey Logic

Static questionnaire scheduling is rapidly becoming obsolete. Future eCOA systems utilize real-time edge computing on wearable devices to monitor physiological anomalies. For example, if a participant's heart rate variability abruptly decreases while skin temperature and nocturnal respiration spike, the Corsano eCOA system automatically prompts an event-specific ePRO questionnaire on the subject's mobile application to capture immediate subjective context.

2. Passive Biometric Identity Verification

A persistent vulnerability in decentralized clinical trials is participant proxy fraud (unauthorized individuals completing survey questionnaires or wearing the device). Next-generation eCOA systems incorporate biometric verification by matching unique continuous photoplethysmography (PPG) optical signatures and single-lead ECG pulse characteristics, ensuring that data integrity remains uncompromised throughout multi-month trials.

3. Multi-Sensor Data Fusion for Complex Disease Endpoints

Therapeutic areas such as oncology, neurology (Parkinson's, Alzheimer's), cardiology, and rare metabolic disorders demand complex endpoint definitions. By fusing continuous activity, gait micro-fluctuations, autonomic nervous system tone (via GSR and HRV), and continuous temperature rhythms, the Corsano eCOA platform enables pharma sponsors to construct endpoints that measure real-world functional recovery far more accurately than intermittent clinic visits.

High-density raw PPG and ECG waveform telemetry for AI-driven digital biomarker discovery in eCOA trials
Granular 128 Hz raw optical and electrical biosignals processed through AI pipelines for digital biomarker verification.

Did You Know?

Corsano Health has generated over 400 billion continuous data points across active clinical trials and hospital wards, establishing one of the industry's most robust biotelemetry reference databases.

Enterprise Expertise & Credentials

Why Global Pharma & CRO Leaders Partner with Corsano Health

Built on European engineering rigor, verified medical certifications, and academic research collaborations.

0Data Points CollectedContinuous physiological signals
0Devices ManufacturedISO 13485 quality control
0Academic HospitalsValidation & clinical use
0Trial ParticipantsAcross diverse global cohorts
0Clinical StudiesCardiology, oncology, neurology
0Vital ParametersContinuous single-device capture
Rigorous Regulatory Compliance

Medically Certified Hardware & Audit-Ready Cloud Architecture

Unlike consumer smartwatches or uncertified software platforms, Corsano Health operates as a fully regulated medical device manufacturer. Our CardioWatch continuous monitoring ecosystem undergoes strict regulatory audits to guarantee clinical validity and compliance.

  • CE-MDR Certification: Audited under European Union Medical Device Regulation by Notified Body Kiwa.
  • FDA 510(k) Clearance: Regulatory clearance supporting commercial clinical trial execution across the US.
  • ISO 13485 Quality Management: End-to-end design, manufacturing, and post-market surveillance.
  • FDA 21 CFR Part 11 Compliance: System audit trails, electronic signatures, data integrity controls.
  • GDPR & HIPAA Alignment: End-to-end encryption, multi-tenant security, anonymized data processing.
Kiwa Notified Body CE-MDR certification badge for Corsano eCOA continuous wearable monitor
Clinical Testimonials

Validated by Leading Researchers & Cardiologists

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.
Prof. Steven Steinhubl, MD Purdue University & Digital Health Research Pioneer
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.
Prof. Niels van Royen, MD, PhD Professor of Cardiology, Head of Department, Radboud University Medical Center
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.
Dr. Eelko Ronner, MD, PhD Cardiologist, Reinier de Graaf Hospital, Netherlands
Collaborative Ecosystem

Trusted by MedTech Leaders, Pharma Sponsors & Research Consortia

Netcare
Medtronic
Roche Diagnostics
Janssen
Philips
Charité Berlin
Radboud University Medical Center
Amsterdam UMC
Erasmus MC
Leiden University Medical Center
Procurement & Technical Intelligence

Frequently Asked Questions (FAQ) for eCOA Procurement

In-depth technical and operational answers to questions frequently asked by AI search tools, CRO project managers, biostatisticians, and procurement directors.

The Corsano eCOA platform is built ground-up to meet regulatory mandates under FDA 21 CFR Part 11 and EU Annex 11. Key technical measures include:

  • Immutable Audit Trails: Every user action, survey entry, vital parameter recording, and system log is time-stamped with cryptographic hash verification.
  • Role-Based Access Control (RBAC): Granular permissions restricting access between trial participants, site investigators, monitor CRAs, and biostatisticians.
  • Electronic Signatures: Authenticated electronic signature workflows for investigator end-of-visit reviews and ePRO validations.
  • Secure Cloud Infrastructure: ISO 27001 certified cloud environments with end-to-end AES-256 bit encryption in transit and at rest.

Unlike consumer fitness trackers that export aggregated summaries, Corsano provides IP-free, unrestricted raw signal access. Research teams can extract raw biosignals sampled at up to 128 Hz via RESTful APIs or bulk CSV/HDF5 formats:

  • Raw multi-wavelength Photoplethysmography (PPG: Green, Red, Infrared)
  • Raw single-lead Electrocardiogram (ECG) voltage waveforms
  • Raw 3-axis Accelerometry (ACC) for micro-movement and tremor analysis
  • Continuous Skin Temperature measurements
  • Galvanic Skin Response (GSR) / Electrodermal Activity (EDA) for autonomic stress response

Data loss is a primary driver of clinical trial cost overruns. The Corsano eCOA platform addresses compliance through dual mechanisms:

1. Passive Sensor Data Integrity: The CardioWatch 287 smart bracelet features internal flash memory capable of buffering up to 30 days of continuous multi-parameter data offline. If a subject disconnects from their mobile gateway or travels without cellular connectivity, data automatically resynchronizes once reconnected without loss.

2. Intelligent ePRO Push Notifications: Customizable smart reminders alert participants when daily or weekly questionnaires are due. If wear-time drops below target thresholds, the research portal alerts site coordinators for proactive participant outreach.

Yes. Corsano provides documented REST APIs, Webhooks, and Mobile SDKs (iOS and Android) that facilitate seamless integration with major industry EDC platforms (such as Medidata Rave, Veeva Vault CDMS, and Oracle Clinical) as well as hospital Electronic Medical Record (EMR) systems like Epic and Cerner via HL7 FHIR protocols.

The CardioWatch 287-2B is engineered for continuous multi-day recording on a single charge depending on sampling configuration (up to 7+ days under typical operational settings). Charging is completed via a magnetic USB dock. The device is IP67 waterproof, allowing subjects to bathe and exercise without removing the band, maximizing wear compliance.

Corsano Health offers flexible commercial arrangements tailored to trial size and duration, including device purchasing, trial hardware leasing, software-as-a-service (SaaS) platform subscription tiers, and comprehensive study provision kits. We support worldwide provisioning with pre-configured gateway smartphones, country-specific cellular SIM cards, and global logistics fulfillment.

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Disclaimer: The Corsano CardioWatch platform is CE-MDR certified and FDA 510(k) cleared. Feature availability and specific eCOA regulatory claims may vary by geographical region depending on local medical device registrations and trial protocol approvals.