eCOA/ePRO

Medrio's eCOA/ePRO solution is an electronic Clinical Outcome Assessment and electronic Patient-Reported Outcome platform designed for clinical trials across the life sciences industry. Built on Medrio's unified clinical data platform, it empowers participants, clinicians, and observers to report outcomes conveniently and accurately, improving data quality and overall study efficiency. The solution is suited for medical technology, biotechnology, pharmaceutical, CRO, and animal health organisations running decentralised, hybrid, or complex trial designs.

Unlike standalone ePRO systems or paper-based approaches, Medrio eCOA/ePRO integrates directly with Medrio's CDMS/EDC environment, creating a single unified data environment that eliminates reconciliation effort, reduces system fragmentation, and supports faster downstream analysis and decision-making.

Core Capabilities

• Web-based, device-agnostic solution that works on any internet-connected device without requiring app downloads, operating system updates, or device compatibility checks
• Supports Bring Your Own Device (BYOD), allowing participants to complete assessments on familiar personal devices and reducing the need for in-clinic visits
• Collects patient-reported, clinician-reported, and observer-reported assessments, including validated instruments and custom questionnaires aligned to protocol requirements
• Configurable survey builder with reusable assessment templates requiring no custom coding
• Supports both in-clinic and remote data collection, making it suitable for decentralised and hybrid trial designs
• Flexible configuration accommodates adaptive and complex study designs where outcome assessments may change over time
• Seamless integration of wearable and external data with the back-end database

Data Quality and Regulatory Compliance

• Built-in audit trails and time stamps on all captured outcome data
• Role-based access controls and secure data transmission to support regulatory expectations for electronic records
• Eliminates errors associated with manual transcription and paper diaries
• Outcome assessments flow directly into the study database, enabling real-time visibility and streamlined data review
• Supports compliant collection of primary and secondary endpoint data for pharmaceutical clinical trials
• Upholds recognised compliance standards across the platform

Participant Engagement and Compliance Features

• Automated notifications and reminders help participants stay on track with diary completion schedules
• Time-based assessment schedules improve diary completion rates and overall data completeness
• MyMedrio participant portal enhances participant compliance and retention
• Intuitive interface reduces burden on both participants and site staff

Study Startup and Operational Efficiency

• Study setup can be completed in as little as four weeks, accelerating the time to begin capturing data
• Quick, intuitive survey builds help teams meet study timelines and reduce costs
• Robust support assists teams in adhering to study protocols and industry standards
• Real-time data access enables monitoring with zero delays between collection and review
• Reduces operational complexity by unifying outcome assessments with broader clinical trial data management

Implementation and Support

• Medrio provides onboarding, training, and ongoing support for eCOA/ePRO implementation
• Dedicated team assistance with study setup, assessment configuration, and operational best practices
• Access to the Medrio Community forum for additional resources and guidance
• Consistent team assignment from project start to finish, as highlighted by customers

Medrio eCOA/ePRO is part of an integrated suite that also includes CDMS/EDC, eConsent, RTSM, Clinical Data Services, and Clinical Trial Project Management, enabling life science teams to manage the full scope of clinical trial data and operations within a single platform. The solution has contributed to real-world outcomes including FDA clearance and doubled clinical trial enrolment for Medrio customers.