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    Next-Gen ePRO Software

    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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    21 CFR Part 11 Compliant
    GDPR Compliant
    SOC 2 Compliant
    ePRO mobile interface showing patient health surveys

    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).

    ~90%
    reduction in missing data vs. paper diaries*
    21 CFR Part 11
    compliant audit trails and e-signatures
    BYOD + Provisioned
    validated on iOS, Android, and web

    * Based on published eCOA literature. Individual study results vary.

    How It Works

    1

    Design

    AI-powered form builder with reusable templates and flexible configuration

    2

    Deploy

    Seamless multi-platform experience with built-in reminders and offline support

    3

    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 DiariesCurebase ePRO
    Data entry errorsManual transcription requiredDirect capture, no transcription
    Missing dataCommon: no real-time alertsAutomated reminders: real-time visibility
    Backdating riskHigh (hoarding)Eliminated via timestamped entries
    Device flexibilityN/AAny iOS, Android, or web device
    Regulatory complianceManual audit trail21 CFR Part 11 compliant audit trail

    Frequently Asked Questions

    Ready to See It in Action?

    See how Curebase can transform your clinical trials.

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