eCOA - Electronic Clinical Outcome Assessments
Unifying patient-reported outcomes (ePRO), clinician assessments (eClinRO), and continuous continuous medical wearable telemetry in one certified digital trial platform.
Digitize Outcome Assessments with Zero Data Friction
Paper-based clinical outcome assessments introduce transcription errors, missing data entries, and protocol non-compliance. Corsano eCOA seamlessly combines validated digital questionnaires with continuous medical-grade wearable data, providing pharmaceutical sponsors and CROs with verifiable, time-aligned clinical endpoints.
Fully Integrated ePRO & eClinRO Workflows
Engineered specifically for clinical operations teams, investigators, and decentralized trial subjects, our eCOA platform covers all qualitative and quantitative trial assessment requirements.
Patient-Reported Outcomes (ePRO)
Enable study participants to record symptoms, quality of life (QoL) questionnaires, and eDiaries via an intuitive mobile app. Smart skip-logic forms prevent incomplete submissions and reduce patient burden.
- • Validated QoL scale integrations
- • Custom symptom tracking & event diaries
- • Multi-language localization & voice guidance
- • Automated push notifications & compliance alerts
Clinician-Reported Outcomes (eClinRO)
Equip Principal Investigators and Clinical Research Coordinators (CRCs) with structured digital assessment workflows. Document standardized clinical ratings directly on site tablets or web portals.
- • Role-based investigator authorization
- • Standardized scoring scales & automated calculations
- • "Today's Visit Tasks" workflow dashboard
- • Real-time protocol deviation monitoring
Observer & Caregiver Outcomes (eObsRO)
Facilitate caregiver-reported assessments for pediatric, geriatric, or cognitively impaired patient cohorts. Capture objective observational data without complex training overhead.
- • Simplified secondary user interface
- • Functional daily activity assessments
- • Medication adherence tracking
- • Encrypted offline response caching
Correlate Subjective Reports with Continuous Vital Signs
Unlike standalone survey software, Corsano eCOA natively connects with the CE-MDR certified and FDA 510(k) cleared CardioWatch 287 medical smart bracelet. Researchers can evaluate subjective symptom flares against continuous physiological signals.
- ✓Continuous Physiological Context: Overlay ePRO symptom triggers against heart rate variability (HRV), continuous SpO2, respiration rate, and skin temperature.
- ✓Functional Mobility Tests: Execute standardized digital mobility tests (such as 6-minute walk tests) using built-in 3-axis accelerometer sensors.
- ✓Offline Local Storage: Complete local caching on the bracelet and mobile app guarantees zero data loss during connectivity outages in remote studies.
- ✓BYOD or Provisioned Deployment: Rapid onboarding through secure QR-code binding on personal smartphones or site-issued provisioned devices.
Technical Specifications & Data Security Standards
Built to meet the stringent security, privacy, and regulatory demands of global pharmaceutical sponsors, contract research organizations (CROs), and institutional review boards (IRBs).
| Regulatory Compliance | FDA 21 CFR Part 11, EU Annex 11, GDPR, HIPAA, ISO 27001, ISO 13485 |
|---|---|
| Deployment Options | Bring Your Own Device (BYOD - iOS & Android) or Provisioned Trial Smartphones/Tablets |
| Data Integration | RESTful APIs, Webhooks, AWS S3 Cloud-to-Cloud Sync, CDISC ODM/SDTM Export Formats |
| Authentication | OAuth 2.0 with Enterprise Single Sign-On (SSO), Role-Based Access Control (RBAC) |
| Data Security | End-to-end AES-256 bit encryption in transit and at rest; isolated multi-tenant architecture per sponsor/protocol |
| Questionnaire Engine | Supports branch/skip logic, visual analog scales (VAS), Likert scales, numeric rating scales (NRS), eDiaries |
Frequently Asked Questions
The Corsano platform automatically time-aligns qualitative ePRO/eClinRO questionnaire submissions with continuous medical-grade physiological telemetry from the CardioWatch 287 bracelet (such as HR, HRV, SpO2, respiration rate, and activity), giving trial sponsors a complete multidimensional view of patient health.
Yes. The platform complies with FDA 21 CFR Part 11, HIPAA, and EU GDPR requirements, featuring full audit logs, encrypted data transmission, role-based access control (PI, Clinical Study Nurse, Sponsor), and validation documentation required for pharmaceutical regulatory filings.
Yes. The Corsano Patient Application features complete offline resilience. Patient responses and continuous physiological data are cached locally on the device or bracelet and automatically synchronized to the cloud once cellular or Wi-Fi connectivity is restored.
Corsano supports both BYOD mobile deployment and fully provisioned study smartphones/tablets. The system includes automated QR-code onboarding, multi-language localization, and investigator dashboard management to streamline trial site workflows.
Accelerate Your Decentralised Trial Outcomes
Request our complete eCOA Technical Specification Dossier, API Documentation, and Regulatory Compliance Validation Package for pharmaceutical procurement.
Feature availability may vary by country or region and is subject to applicable regulatory approvals, clearances, and local regulatory requirements.