ePRO

Clincase ePRO is an electronic patient-reported outcomes solution designed to place study participants at the center of clinical trials. It supports both decentralized and hybrid trial models by enabling participants to submit data from their own devices while giving site staff and project personnel real-time access to collected information.

The platform combines a mobile app and web interface with integrated site management tools, aiming to reduce manual data entry, minimize on-site monitoring burden, and improve the reliability of data captured closest to the actual event.

Data Collection and Reliability

• Captures data with timestamps to support accurate, event-proximate data collection.
• Automated data capture reduces the need for manual entry and on-site monitoring.
• Real-time, online access to ePRO data supports collaboration and decision-making across all project personnel.
• Instant data validations and checks are built into the forms to support high-quality data entry.

Participant-Facing Features

• Supports a bring-your-own-device (B.Y.O.D.) approach, allowing participants to use their existing smartphones, tablets, or browsers.
• Mobile app includes biometric authentication and push notification reminders.
• Dynamic questionnaires with the ability to allow response changes after initial submission.
• User-friendly interface with simplified forms designed for ease of use.
• Configurable automated push notification reminders to encourage timely data entry.
• Personalized avatars provide a visual representation of the participant within the ePRO interface to support engagement.
• Study news and travel plan features are available within the participant experience.
• Online participant status and messaging functionality is included.

Video Calls

• Secure video calls between participants and investigators are available directly within the Clincase ePRO solution.
• No third-party video conferencing software is required, supporting remote communication in decentralized or hybrid trials.

Site Staff and Monitoring Tools

• Clinical site staff have access to real-time ePRO usage insights for individual participants.
• Integrated tools support one-way reminder messages and participant account management.
• ePRO data is available in real time within the EDC system.

Clincase ePRO integrates directly with the Clincase EDC, making it part of a broader e-clinical technology platform. The solution is accessible via both web and mobile app, and is designed to support decentralized, hybrid, and traditional trial formats without requiring additional external tools for communication or device management.