oomnia eSource

oomnia eSource is an electronic source data capture solution developed by Wemedoo for use in clinical trials. It replaces paper-based source documents with direct electronic capture at the point of care, so that data entered by site staff serves simultaneously as the source document and the eCRF. The system is designed for sponsors, CROs, research sites, and hospitals running site-based or decentralized trials, and is part of the broader oomnia unified clinical trial platform.

Data captured through oomnia eSource is structured, validated, and available in real time to all stakeholders — sponsors, sites, and CROs — working from a single shared database. Wemedoo applies clinical knowledge to standardize and structure data so it is ready for regulatory reuse from the moment of capture. The platform holds certifications and compliance status covering ISO 27001, SOC 2, FDA 21 CFR Part 11, GDPR, HIPAA, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+.

Core Data Capture Capabilities

• Source data is captured electronically at the point of care, eliminating manual transcription from paper to EDC entirely.
• Data entered once serves as both the source document and the eCRF — no duplicate data entry.
• Data is available instantly for monitoring, review, and analysis without waiting for site visits or batch uploads.
• A single database with a full audit trail gives all stakeholders access to the same validated data set with complete traceability.
• Direct data entry supports source data verification remotely and enables smooth translation of protocols into real-world clinical workflows.
• The system supports central readings and advanced use cases including visit notes and lab assessments.

Integration and Interoperability

• Connects with EHR systems, laboratory systems (LIMS), IoT devices, and wearables using HL7 FHIR standards.
• Data flows directly into the trial database from connected sources, eliminating batch uploads and manual reconciliation.
• Built on Common Data Elements aligned to international interoperability standards, allowing the data model to adapt to the clinical terminology used at each site.
• Supports collection of diverse data types including vital signs, voice notes, lab reports, and data from home-monitoring devices via an IoT-ready engine.
• Fully integrated with the oomnia EDC module within one unified system — no separate reconciliation required.
• Data is structured to be reusable and interoperable, and is ready for regulatory submission from the moment of capture.

Form Builder and Protocol Design

• A visual drag-and-drop form builder allows clinical data managers to create, modify, and deploy eCRFs without programming.
• Supports pre-validated field types, conditional logic, and edit checks built directly into the form design interface.
• Every form automatically enforces data validation rules, range checks, and protocol-defined constraints for 21 CFR Part 11 compliance.
• Forms are built on Common Data Elements aligned to CDISC standards, accelerating dataset generation and regulatory submission.
• Pre-built templates are available to reduce form design timelines and speed up trial launch.

Data Quality and Oversight

• Built-in consistency checks catch errors at the point of entry, reducing the need for downstream corrections.
• Real-time data synchronization keeps all connected systems aligned continuously.
• Live reports bring together all data streams for full trial visibility.
• Continuous monitoring of data entries and protocol compliance is available in real time.
• Automated data flows and digital source documentation reduce manual work and lower operational costs.

Security, Compliance, and Collaboration

• Sensitive data is protected with 21 CFR Part 11–compliant encryption, secure login protocols, and role-based access controls.
• All user actions are logged and traceable, supporting full audit readiness for regulatory inspections.
• Sponsors, sites, and CROs connect through secure shared workspaces with real-time access to the same data set.
• Complete audit trails and electronic signatures are maintained in accordance with FDA, EMA, and ICH GCP E6(R2) requirements.

Documented Case Study Outcomes

• 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 after the last patient visit.
• Medical Device Real-World Evidence Study: Integrated retrospective data collection and prospective ePRO arms; used oomnia EDC, eConsent, and ePRO together; implemented dynamic eCRF automation and real-time consent tracking.
• Phase IV Pediatric Study: Developed a protocol deviation log with real-time reporting by country, site, and participant; implemented automated role-based email alerts; dynamic form behaviors reduced redundant questions and cut deviation tracking and resolution time.

oomnia eSource is delivered as part of the oomnia SaaS platform, which also includes EDC, RTSM, eTMF, CTMS, ePRO, eCOA, and eConsent modules — all operating on a single instance and sharing one database. Organizations can select individual modules and configure the platform to fit their specific workflows. Wemedoo reports 83% faster trial setup compared to a major global CRO for an equivalent trial, 100% real-time trial oversight, and 100% client retention.