ePRO

Octalsoft ePRO (Electronic Patient Reported Outcomes) is a mobile-first software platform designed to capture, validate, and analyze patient-reported data in real time across clinical trials. It is built for sponsors, CROs, and site teams who need to improve patient adherence, reduce administrative burden at sites, and support faster clinical decision-making. The platform combines AI-driven engagement tools with secure data collection across smartphones, tablets, and web browsers.

Octalsoft ePRO is part of the broader Octalsoft eClinical Suite and integrates natively with EDC, IWRS/RTSM, CTMS, and rSDV modules. It is designed to meet global regulatory standards including 21 CFR Part 11, GDPR, and HIPAA.

Core Capabilities

• AI-Driven Patient Engagement: Customizable dashboards visualize site performance, query status, and SDV compliance metrics. AI-driven insights predict trends and highlight outliers, and automated reporting supports decision-making for sponsors and CROs.
• Real-Time Data Capture and Validation: Patients can enter data securely via smartphone, tablet, or web. AI-driven edit checks flag incomplete or inconsistent responses, and data syncs in real time for immediate investigator access. Supports multimedia inputs including images, audio, and wearable device data.
• Intelligent Compliance Monitoring: AI tracks patient adherence and flags potential risks. Automated alerts notify sites of missed or delayed entries, and predictive analytics forecast patient retention trends.
• Workflow Integration: Native integration with Octalsoft EDC, IWRS, CTMS, and rSDV. Direct data reconciliation eliminates transcription errors, and AI links patient-reported outcomes to clinical endpoints.
• Advanced Analytics and Insights: Customizable dashboards visualize patient outcomes and compliance trends. AI detects patterns across patient cohorts, and export-ready datasets are available for regulatory submissions.
• Data Security and Compliance: End-to-end encryption protects patient-reported data across all devices. Role-based access control restricts data visibility to authorized personnel, and automated audit trails maintain full traceability of all data interactions.

Role-Specific Benefits

• Sponsors: Access unified real-world patient data, reduce compliance risks through centralized oversight, and integrate patient insights across all stages of a study.
• CROs: Standardize patient engagement processes across global studies and sponsors, manage operations through centralized dashboards with predictive analytics, and maintain consistency and scalability across patient touchpoints.
• Site Teams: Reduce administrative burden through automated compliance and adherence tracking, monitor patient engagement in real time to support retention, and maintain communication with trial participants throughout the study.

Available Add-Ons and Integrations

• Octalsoft EDC: Integrates ePRO with the study database for real-time data validation and analysis.
• Octalsoft IWRS/RTSM: Connects patient-reported outcomes with randomization and supply management workflows.

Platform and Support

• Operates as part of an all-in-one eClinical platform covering planning, operations, data capture, and analytics across the trial lifecycle.
• Designed to meet global regulatory standards including 21 CFR Part 11, GCP, and GDPR.
• Offers personalized onboarding, 24/7 support, and ongoing optimization services.

Octalsoft ePRO is available as a standalone module or as part of the integrated Octalsoft eClinical Suite. Supporting resources include a case study on ePRO integrated with IWRS and a downloadable product factsheet.