oomnia EDC

oomnia EDC is an electronic data capture system developed by Wemedoo for managing clinical trial data. It is designed for clinical data managers, sponsors, and CROs running complex, global trials. The platform replaces paper-based case report forms with electronic CRFs, supporting real-time data entry, automated validation, and regulatory-ready data exports. It is certified under ISO 27001 and SOC 2, and complies with FDA 21 CFR Part 11, GDPR, HIPAA, and ICH GCP requirements.

oomnia EDC is part of the broader oomnia ecosystem — a unified SaaS platform that also includes CTMS, eTMF, RTSM, eSource, ePRO, eCOA, and eConsent modules, all operating on a single instance. This native integration eliminates the need for separate data reconciliation between systems and provides a single source of truth across all trial data.

Core Features

• No-code eCRF designer: CRFs are built using a drag-and-drop interface with built-in templates, field validations, and logic rules. No programming is required, and mid-study updates are supported.
• Automated query management and edit checks: Tasks are routed automatically to the appropriate users. Edit checks run in real time, discrepancies are flagged immediately, and role-specific views show only relevant information to each user.
• CDISC-compliant data export: Data is exportable in SDTM format and is fully CDISC-compliant without requiring separate CDASH programming, accelerating regulatory submission preparation.
• Real-time dashboards and reporting: Custom reports, dashboards, and statistical analyses can be generated directly within the system. Data is structured and analysis-ready at all times.
• Built-in business analytics: Data flows directly into integrated analytics without additional steps or external tools.
• Advanced participant dashboards: Provides a detailed view of each participant's journey, including data entry status, query resolution, source data verification (SDV) progress, and study milestones.
• Automated notifications: Instant alerts are sent for query responses, protocol deviations, and milestone deadlines.
• Granular role-based access control: Permissions are managed across all trials and modules with single sign-on. Role-specific views reduce cognitive load and navigation time.
• RTSM integration: Supports instant randomization of investigational product kits with automated tracking within the RTSM module.

Clinical Data Lifecycle Workflow

1. eCRF design and setup: Studies are configured using the drag-and-drop form designer with reusable templates and built-in validation rules, reducing time-to-first-patient.
2. Automated query management: Edit checks run continuously during data entry. Discrepancies are flagged in real time and routed to the correct users, reducing manual review time for monitors and sites.
3. Data submission and regulatory readiness: Data is exported in SDTM/CDISC format, removing the need for manual preparation and accelerating regulatory submissions.

Reported Performance Metrics

• Up to 83% faster trial setup compared to a major global CRO for an equivalent study with 5,000 CRF questions.
• Up to 66% reduction in manual queries reported by clients.
• Up to 75% reduction in navigation time through role-based access and streamlined interface design.
• 100% client retention reported.

Case Study Highlights

• Ophthalmology medical device and drug study: Managed a study with over 5,000 CRF questions using dynamic eCRF features. Design, implementation, UAT, and site training were completed in 9 weeks. 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. Used oomnia EDC alongside eConsent and ePRO modules for unified data collection, consent tracking, and patient engagement.
• Phase IV pediatric study: Implemented a protocol deviation tracking log with real-time reporting by country, site, and participant. Automated role-based email alerts were configured for timely review and approval of deviations.

oomnia EDC is deployed as a SaaS solution and supports multiple trials on a single instance. It includes full audit trails, electronic signatures, and data encryption to maintain compliance with applicable regulatory frameworks. The platform integrates natively with other oomnia modules including CTMS, eTMF, RTSM, ePRO, eCOA, and eConsent, and is hosted under Swiss data privacy standards.