Electronic Patient Reported Outcomes (ePRO) for Clinical Trials
Build ePRO studies faster and create engaging participant experiences with an intuitive, flexible platform designed for modern clinical trials.
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Patient-Friendly ePRO That Study Teams Love Too
Works on any device
iOS, Android, tablet, and desktop supported
Provisioned or BYOD
Flexibility for device deployment
Multi-language by design
Global language support built in
Engage with text, email, SMS
Automated reminders and notifications
Pre-built instrument library
Ready to deploy without manual buildout
AI-powered
Conversational AI form builder
ePRO Is Part of a Complete eCOA Solution
Electronic clinical outcome assessments (eCOA) cover four data types that clinical trials rely on: patient-reported (ePRO), clinician-reported (eClinRO), observer-reported (eObsRO), and performance outcomes (ePerfO). Curebase captures all four on a single platform, including eCOA Vigilance for real-time data monitoring and query management, so your study team manages one system, one validation package, and one vendor relationship.
ePRO is a type of eCOA, specifically an assessment completed by the patient themselves, as distinct from assessments completed by clinicians (eClinRO) or caregivers (eObsRO).
* Based on published eCOA literature. Individual study results vary.
How It Works
Design
AI-powered form builder with reusable templates and flexible configuration
Deploy
Seamless multi-platform experience with built-in reminders and offline support
Analyze
Full compliance with audit trails, real-time queries, and exportable reports
Regulatory Compliance
Curebase ePRO is built to FDA 21 CFR Part 11 requirements for electronic records, with a complete audit trail, role-based access controls, and validated electronic signatures at every data capture point. The platform is also GDPR-compliant and SOC 2 Type II certified, supporting global trials across regulatory jurisdictions.
Assessments follow FDA Clinical Outcome Assessment (COA) guidance for content validity and measurement equivalence between paper and electronic administration.
Therapeutic Areas
Curebase ePRO is used across therapeutic areas including oncology, pain management, dermatology, mental health, rare disease, and cardiovascular trials, wherever capturing the patient voice directly drives regulatory and clinical decisions.
Why ePRO Outperforms Paper in Clinical Trials
| Paper Diaries | Curebase ePRO | |
|---|---|---|
| Data entry errors | Manual transcription required | Direct capture, no transcription |
| Missing data | Common: no real-time alerts | Automated reminders: real-time visibility |
| Backdating risk | High (hoarding) | Eliminated via timestamped entries |
| Device flexibility | N/A | Any iOS, Android, or web device |
| Regulatory compliance | Manual audit trail | 21 CFR Part 11 compliant audit trail |
