ePRO

Prelude's ePRO (Electronic Patient-Reported Outcomes) is a clinical trial software tool that allows study participants to report symptoms, side effects, quality-of-life data, and other outcomes directly from their own smartphones, tablets, or computers. It is designed for research teams and sponsors who need to replace paper-based data collection and reduce reliance on in-person site visits, enabling real-time data capture that flows directly into an Electronic Data Capture (EDC) system.

The tool targets clinical trial teams across therapeutic areas including oncology, CNS, rare disease, and infectious disease, as well as industries such as biotech, pharmaceuticals, medical devices, and academia. By collecting data electronically at the source, Prelude's ePRO reduces transcription errors, supports participant compliance through automated reminders, and keeps study teams aligned through a unified data system.

Core Data Collection Features

• Participants can submit data from any personal device, including smartphones, tablets, and computers.
• Flexible data entry field types include text fields, numerical fields, clocks and calendars, visual analog scales (VAS), radio options, checkboxes, and media uploads such as photos and videos.
• Surveys can be dynamically displayed per participant, including both scheduled entries and always-available surveys through a tailored survey view.
• Built-in timestamps and validations are applied at the point of data entry to reduce errors and follow-up work.
• Detailed audit trails track every entry with fully attributable, timestamped data posted directly to the study database.

Automation and Notifications

• Automated reminders are delivered via text or push notifications to keep participants on schedule with data submissions.
• Survey alerts can be scheduled automatically to maintain consistent data collection across the study timeline.
• Automated compliance features eliminate missed surveys and reduce the need for manual follow-up by research staff.

EDC Integration and Data Syncing

• Participant entries sync in real time to Prelude's EDC, providing immediate access to study data for research teams.
• Data collected remotely flows directly into the EDC, keeping site teams and sponsors aligned within one unified system.
• Real-time syncing supports timely monitoring and reduces delays associated with manual data entry or paper form transcription.

Participant Experience

• The interface is designed to be intuitive and accessible, including for participants who may have limited technical experience.
• Participants can use their own devices without needing dedicated study hardware.
• Automated reminders and reduced site visit requirements are intended to keep participants engaged throughout the trial.
• Media upload functionality allows participants to submit photos and videos as part of their reported outcomes.

Compliance and Security

• Prelude's ePRO is designed to meet 21 CFR Part 11, GDPR, and ICH GCP requirements.
• Built-in audit trails, secure access controls, and validated workflows are included to protect data integrity.

Prelude's ePRO is part of a broader platform that also includes EDC, eConsent, and RTSM capabilities, and is available with CRO partnership and professional services support. The tool is accessible via a mobile app and web interface, with data management centralized within Prelude's integrated clinical trial system.