Enabling Patient-Centric Real-World Evidence Through Integrated EDC and ePRO Solutions

🎯 The Challenge

The study required a robust digital solution capable of supporting both investigator-driven data collection and direct patient input through electronic patient-reported outcomes (ePRO). Real-world evidence studies involve complex workflows, multiple stakeholders, and diverse data sources. The solution could support:

Efficient Clinical Data Collection

A flexible EDC platform was needed to capture investigator-reported information while supporting evolving study requirements.

Patient-Centric Data Collection

The study required an intuitive ePRO solution to enable participants to provide health-related information directly and conveniently.

Data Quality and Oversight

The solution needed to ensure standardized data collection, automated validation, and improved visibility into study progress.

Operational Efficiency

Study teams required streamlined processes to reduce manual activities and support effective study management.

Adverse Event Reporting

The study required a solution to enable fast, reliable capture of adverse events and generate reports containing critical safety details, so the safety team could receive prompt updates throughout the study.

💡 Our Solution

Clincase delivered a fully integrated EDC and ePRO environment designed around the study protocol.

Intelligent EDC–ePRO Integration

Clinical data entered by study sites automatically triggered patient activities within the ePRO application. Questionnaire availability was driven by predefined study rules, reducing manual coordination while ensuring participants received the correct assessments at the appropriate time.

This integration enabled patient-reported outcomes to become a natural extension of the clinical workflow rather than a separate process.

Advanced Schedulling Logic

One of the most sophisticated aspects of the implementation was the configuration of complex scheduling rules.
The solution automatically generated questionnaires based on:

• completed study visits
• planned visit dates
• visit windows
• skipped visits where study participation continued
• participant discontinuation status
• disease-specific eligibility criteria

This event-driven automation ensured patients received only the questionnaires relevant to their study journey.

Patient-Centric ePRO Experience

Participants completed questionnaires through the Clincase mobile application using their own smartphones.

The implementation included:

• six validated electronic questionnaires
• recurring medication diaries
• biometric authentication
• automated reminder notifications
• configurable questionnaire expiry and locking rules
• German-language user interface

The BYOD approach reduced operational burden while making participation more convenient for patients.

🌟 Key Success Factors

Strong collaboration between CRO, Sponsor and Clincase

Clear governance, well-defined roles and responsibilities, and continuous communication throughout requirements gathering, configuration, testing, validation, and deployment ensured the solution met study objectives and was delivered on schedule.

Enhanced Patient Engagement

The mobile-first BYOD approach enabled participants to complete assessments conveniently while automated reminders supported questionnaire compliance throughout the multi-year follow-up period.

Flexible Platform Configuration

Clincase's configurable architecture accommodated complex visit schedules, conditional questionnaire logic, reminder workflows, and country-specific localization without requiring extensive custom development.

👉🏻Interested in discovering how we can tailor a solution to fit your study’s needs?
Schedule a demo with Monique today!