ePRO/eCOA

Curebase ePRO/eCOA is a clinical trial software platform designed to capture electronic patient-reported outcomes (ePRO) and broader electronic clinical outcome assessments (eCOA) across all four data types: patient-reported (ePRO), clinician-reported (eClinRO), observer-reported (eObsRO), and performance outcomes (ePerfO). The platform is intended for study teams running modern clinical trials who need to reduce missing data, maintain regulatory compliance, and support participants across multiple devices and languages.

Curebase consolidates ePRO, eConsent, participant recruitment, EDC, engagement tools, and eCOA Vigilance for real-time data monitoring into a single platform, with one validation package and one vendor relationship. The platform is used across therapeutic areas including oncology, pain management, dermatology, mental health, rare disease, and cardiovascular trials.

Device and Participant Support

• Supports iOS, Android, tablet, and desktop devices
• Compatible with both provisioned devices and bring-your-own-device (BYOD) deployments, validated on iOS, Android, and web
• Built-in multi-language support for global trials
• Automated reminders and notifications delivered via text, email, and SMS to support participant engagement
• Offline support included for uninterrupted data capture

Form Building and Instrument Library

• AI-powered conversational form builder for creating assessments
• Reusable templates and flexible configuration options
• Pre-built instrument library available for deployment without manual buildout

ePRO vs. Paper Diaries

• Direct data capture eliminates manual transcription and associated entry errors
• Automated reminders and real-time visibility reduce missing data, with approximately 90% reduction in missing data reported versus paper diaries based on published eCOA literature
• Timestamped entries eliminate backdating risk associated with paper diary hoarding
• 21 CFR Part 11 compliant audit trail replaces manual paper-based audit processes

eCOA Vigilance and Data Monitoring

• Real-time data monitoring included through the eCOA Vigilance module
• Query management tools available within the same platform
• Exportable reports for analysis and review

Workflow Steps

1. Design: Use the AI-powered form builder with reusable templates and flexible configuration to build assessments
2. Deploy: Deliver a multi-platform participant experience with built-in reminders and offline support
3. Analyze: Access full compliance audit trails, real-time queries, and exportable reports

Regulatory Compliance

• Built to FDA 21 CFR Part 11 requirements for electronic records
• Complete audit trail and role-based access controls at every data capture point
• Validated electronic signatures included
• GDPR-compliant for global trial support
• SOC 2 Type II certified
• Assessments follow FDA Clinical Outcome Assessment (COA) guidance for content validity and measurement equivalence between paper and electronic administration

Curebase ePRO integrates with other modules on the Curebase platform, including EDC, eConsent, and site management tools (Sitebase), allowing study teams to manage all clinical trial data operations within a single system.