oomnia eCOA

oomnia eCOA is an electronic Clinical Outcome Assessment platform developed by Wemedoo, designed to capture clinical outcome data from patients, caregivers, and clinicians directly on smartphones, tablets, or computers. It supports all four eCOA assessment types — Patient-Reported Outcomes (ePRO), Clinician-Reported Outcomes (ClinRO), Observer-Reported Outcomes (ObsRO), and Performance Outcomes (PerfO) — making it suitable for a wide range of therapeutic areas and trial designs, including decentralized and hybrid studies.

The platform is part of the broader oomnia ecosystem, a unified SaaS clinical trial suite that also includes EDC, RTSM, eTMF, CTMS, eConsent, ePRO, and eSource modules. All modules operate on a single instance, enabling native interoperability across the full trial data lifecycle. oomnia eCOA is validated and certified to meet ISO 27001, SOC 2, FDA 21 CFR Part 11, GDPR, HIPAA, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+ requirements.

Core eCOA Features

• Universal data capture: Integrates structured forms, unstructured notes, biomarkers, sensor data, IoT inputs, and adaptive surveys into a single platform.
• BYOD support: Participants can use their own smartphones, tablets, or computers, with no specialised hardware required and minimal setup.
• Patient-centred interface: An intuitive, mobile-friendly design with a dedicated participant landing page and clear guidelines to support users of all digital literacy levels.
• Real-time data integration: Data captured via eCOA is immediately synchronised with connected oomnia modules including EDC, RTSM, and CTMS.
• Validated instruments: Supports PRO-CTCAE, EQ-5D, SF-36, VAS scales, ECOG performance status, patient diaries, caregiver observations, and custom questionnaires.
• Customisable forms: Forms and IoT inputs can be tailored to match individual study protocols and requirements.
• Adaptable trial design support: Handles both subjective outcomes and objective assessments across diverse protocol types.

Data Quality and Compliance Capabilities

• Real-time validation: Immediate edit checks catch data discrepancies at the point of entry, reducing errors and improving data quality.
• Full audit trails: Detailed, time-stamped logs provide complete traceability and support inspection readiness.
• Automated compliance reminders: Proactive notifications help maintain participant compliance and ensure timely data capture.
• Industry standard enforcement: Automatically applies data standards to produce uniform, analysis-ready datasets.
• Regulatory compliance: Meets 21 CFR Part 11, HIPAA, GDPR, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+ requirements.

Trial Operations and Analytics

• Real-time analytics and reporting: Provides immediate access to trial data to support faster decision-making and study oversight.
• Automated role-based alerts: Configurable email notifications alert designated roles for review and approval actions.
• Smart reminders: Scheduled notifications keep participants and site staff on track throughout the study.
• Automated data management: Reduces manual tasks associated with data handling, lowering operational costs.
• Protocol deviation tracking: Supports real-time reporting of deviations by country, site, and participant.

Decentralized and Hybrid Trial Support

• Patients, clinicians, and caregivers can complete assessments securely from any location on any device.
• Maintains the same data quality and compliance standards as traditional site-based assessments.
• Supports remote data collection without requiring additional infrastructure at participant sites.

Case Study Highlights

• 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 9 weeks, and database lock was achieved within 2 weeks of the last patient visit.
• Medical device real-world evidence study: Integrated retrospective data collection and prospective ePRO arms using oomnia EDC, eConsent, and ePRO, with dynamic eCRF automation and real-time consent tracking.
• Phase IV paediatric study: Implemented a protocol deviation log with real-time reporting by country, site, and participant, automated role-based alerts, and dynamic form behaviours to reduce redundant data entry and speed up deviation resolution.

oomnia eCOA is delivered as part of Wemedoo's modular, fully interoperable oomnia platform. Organisations can select only the modules they require and integrate with existing systems. Wemedoo holds ISO 9001 and ISO 27001 certifications and provides dedicated technical support and training throughout the clinical trial lifecycle.