ePRO

Clinion ePRO (Electronic Patient Reported Outcome) is a compliant, mobile-enabled platform designed to capture patient-reported outcomes directly from patients in clinical trials, without intermediaries. It is suited for sponsors and clinical teams running studies of varying scales — from single-site investigations to large, multi-regional trials — and addresses the growing regulatory demand for real-world data (RWD) and real-world evidence (RWE).

The platform operates either as a standalone solution or integrated with Clinion EDC. As a standalone system, it independently captures patient-reported data for surveys, questionnaires, and studies outside an EDC environment. When integrated with Clinion EDC, it enables consistent data flow and coordinated management across both platforms. Clinion ePRO has been used in studies involving over 20,000 patients and is accessible via iOS, Android, and web browsers.

Core Features

• Multilingual interface: The platform supports multiple languages with no significant learning curve for patients, and includes automated reminders and push notifications to keep patients engaged and on schedule.
• BYOD (Bring Your Own Device) model: Patients use their own smartphones, tablets, or computers running iOS, Android, or web browsers, removing the need for study-provided devices.
• Licensed health questionnaires: Includes trusted, validated instruments such as EQ-5D-5L and PROMIS, which can be customised to fit specific study requirements.
• AI-powered validation: Real-time field validations combined with AI-driven comparison of ePRO and EDC data detect discrepancies early, reducing manual queries and supporting overall data quality.
• Complete audit trail: All data changes are logged automatically to maintain regulatory compliance and data integrity.

Workflow Steps

1. Study Setup: Clinion configures and customises ePRO forms with multilingual support, preparing them for patient use.
2. Patient Data Collection: Patients submit responses through the Clinion ePRO mobile app, with automated reminders to support timely completion.
3. Real-Time Validation and Syncing: Data entries are validated instantly for accuracy and synced securely with Clinion EDC, or stored in standalone mode.
4. Ongoing Monitoring: Clinical teams access real-time patient data through dashboards for immediate review and decision-making.
5. Audit Trail: All changes are automatically logged to support regulatory compliance requirements.

Scope and Distinctions

• ePRO captures outcomes reported solely by patients and is a subset of the broader eCOA (electronic Clinical Outcome Assessment) category, which also includes clinician-reported (ClinRO), caregiver-reported (ObsRO), and performance-based (PerfO) assessments.
• Clinion ePRO does not capture caregiver or clinician assessments; those require a broader eCOA platform.
• Integration with third-party EDC systems is supported where those systems provide accessible APIs, with data transfer that is encrypted and audit-ready.

Integrations with Clinion Suite

• Clinion ePRO can be extended by integrating with other Clinion solutions including EDC, RTSM, eProtocol, eSource, eConsent, CTMS, CSR Automation, and eTMF.

Clinion ePRO complies with global data privacy and security standards including HIPAA and GDPR. The platform is built under Clinion's Responsible AI principles, which cover accountability, transparency, privacy and security, reliability and safety, and fairness.