ePRO

The ePRO system allows patients and clinicians to electronically report outcomes via web platforms and handheld devices, enhancing accuracy in clinical trial data collection by replacing paper diaries and manual entry with real-time digital input.

Participants have secure access to record experiences, symptoms, and quality-of-life metrics, which provides clinicians and trial teams immediate access to validated data, increasing study precision and compliance.

Product Features

• Multi-Device Access: Collect patient data using smartphones, tablets, or web applications for convenience.
• Real-Time Data Capture: Responses are recorded instantly, allowing continuous monitoring of results.
• Customizable Questionnaires: Create study-specific questionnaires with flexible templates to capture relevant information.
• Reminders and Notifications: Automated alerts help participants to stay on track, minimizing missing data.
• Offline Data Entry: Data entry can occur without internet access, syncing automatically when connected.
• Integration with EDC and CTMS: Seamlessly integrate ePRO data with existing trial systems for cohesive insights.
• Regulatory Compliance: Compliant with FDA 21 CFR Part 11, HIPAA and ICH-GCP guidelines.

Key Benefits

Implementing the ePRO system enhances engagement and delivers higher quality clinical outcomes data.

FAQs (Frequently Asked Questions)

• Can patients without smartphones use ePRO? Yes, outcomes can be reported through web portals or provided devices.
• Is ePRO data legally valid? Yes, it meets 21 CFR Part 11 and global regulatory standards.
• Can questionnaires be customized for different studies? The system supports complete customization of forms and templates.
• How is missing data reduced? Automated notifications ensure timely completion of patient entries.
• Can ePRO integrate with EDC and CTMS systems? Yes, it allows for seamless integration, maintaining consistency with existing data systems.