oomnia ePRO

oomnia ePRO is an electronic patient-reported outcomes solution developed by Wemedoo, designed for use in clinical trials. It allows trial participants to report health outcomes, symptoms, and treatment impacts directly through their own digital devices in real time, capturing data that flows into a centralised, analysis-ready format. The tool is aimed at clinical sponsors, CROs, and study teams seeking to improve data quality, reduce administrative burden, and maintain live oversight of patient compliance throughout a trial.

oomnia ePRO is part of the broader oomnia platform — a unified, modular SaaS system that also includes EDC, RTSM, eTMF, CTMS, eSource, eCOA, and eConsent. All modules operate within a single instance, enabling direct data flow between components without manual reconciliation. The platform is developed in Switzerland and operates under Swiss data privacy standards.

Data Collection and Device Support

• Patients can submit data via smartphone (iOS and Android), tablet, laptop, or desktop computer using a responsive web-based interface.
• No trial-specific provisioned devices or app installations are required.
• If a patient's device is lost or replaced, assessments can be resumed immediately via a secure link sent by SMS or email.
• Responses are time-stamped to prevent backfilling.

Key Features and Capabilities

• Customisable surveys: Questionnaires can be delivered in any format, length, or language. Validated instruments such as PRO-CTCAE, EQ-5D, and SF-36 can be configured, or custom scales can be built using a drag-and-drop form designer. Dynamic response flows can be tailored to individual study protocols.
• No-programming setup: Instruments can be configured without programming. ePRO delivery can be triggered automatically based on eCRF completion events.
• EDC and eCRF integration: Because oomnia ePRO is part of the unified oomnia system, data flows directly into the EDC in real time, eliminating manual data transfers and reconciliation steps.
• Real-time data validation: Built-in edit checks validate data at the point of entry. Automated flagging identifies inconsistencies, outliers, and missing data.
• Integrated graphical reports: Real-time reports combine eCRF and ePRO data, giving study staff an on-the-spot overview of instrument completion and trial status.
• Live trial oversight: Data quality and patient compliance can be monitored as they occur, supporting timely decision-making.
• Automated alerts and reminders: Notifications are sent to patients to prompt timely completion of assessments and questionnaires.
• BYOD support: Built-in bring-your-own-device support reduces the need for provisioned hardware, lowering operational costs.
• Patient data protection: Data encryption, multi-factor authentication, and role-based access controls are applied to protect sensitive patient information.
• Multilingual support: Patients can complete assessments in their preferred language.

Reported Operational Outcomes

• Up to 75% reduction in navigation time.
• Up to 66% reduction in manual queries.
• No programming required for instrument setup.

Case Study Examples

• Ophthalmology medical device and drug study: Managed a study with over 5,000 CRF questions; dynamic eCRF features reduced manual queries by 66%. Design, implementation, UAT, and site training were completed in nine weeks. Database lock was achieved within two weeks of the last patient visit.
• Medical device real-world evidence study: Integrated retrospective data collection and prospective ePRO arms. oomnia EDC, eConsent, and ePRO were used together to manage data collection, consent, and patient engagement. Dynamic eCRF automation and real-time consent tracking were implemented.
• Phase IV paediatric study: Developed a protocol deviation log with real-time reporting by country, site, and participant. Automated role-based email alerts were configured for timely review and approval. Dynamic behaviours reduced redundant questions and time required to track and resolve deviations.

Compliance and Certifications

• Compliant with 21 CFR Part 11, HIPAA, GDPR, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+.
• ISO 9001 certified (quality management) and ISO 27001 certified (information security).

oomnia ePRO is available as a standalone module or as part of the full oomnia suite. Organisations can select only the modules relevant to their workflow. The platform supports multiple concurrent trials on a single instance and is designed for interoperability with existing clinical systems.