oomnia eConsent

oomnia eConsent is an electronic informed consent platform developed by Wemedoo for use in clinical trials. It replaces paper-based consent forms with interactive digital documents, supporting patient onboarding through multimedia content, multilingual forms, and secure electronic signatures. The platform is designed for sponsors, sites, and research teams seeking to simplify enrollment, maintain regulatory compliance, and integrate consent workflows with broader clinical trial systems.

oomnia eConsent is part of the broader oomnia ecosystem — a unified SaaS platform that also includes EDC, RTSM, eTMF, CTMS, eSource, ePRO, and eCOA modules, all operating on a single instance. Users can select individual modules and configure them to fit their study workflows.

Core eConsent Features

• Digital and paper consent options: Participants can choose between digital or paper-based consent, allowing sites to accommodate varying patient needs and access levels.
• Digital signatures: Supports advanced electronic signatures with multi-signature workflows and complete traceability, reducing consent timelines from weeks to minutes.
• Multilingual support: Consent documents can be delivered in over 20 languages, automatically presented in the participant's preferred language to support global trials and local regulatory requirements.
• Multimedia engagement: Interactive videos, Q&A sections, and rich media content are embedded in the consent process to help participants understand complex trial information.
• Instant participant support: Integrated Q&A tools provide on-demand guidance accessible on any device.
• Real-time action alerts: Immediate notifications flag incomplete processes or required actions to keep trial timelines on track.
• Device accessibility: The web-based solution functions on smartphones, tablets, and computers without requiring dedicated hardware.

Integration and Data Management

• EDC and CTMS connectivity: oomnia eConsent connects natively with the EDC system, automatically updating consent status in patient records and eliminating manual tracking. This ensures no data is collected before consent is obtained and provides real-time enrollment visibility across all sites.
• Integrated consent ecosystem: Participant data is synchronised across systems, reducing manual data entry tasks.
• Dynamic reporting: Custom graphical or tabular reports can be generated from EDC data with role-based access, supporting audit-ready documentation.
• Custom data exports: Users can export tailored data listings by selecting specific visits, pages, or fields relevant to their study.

Compliance and Security

• Compliant with FDA 21 CFR Part 11, HIPAA, GDPR, ICH GCP, Swiss Data Privacy Law, and FAIR ALCOA+ principles.
• Certified under ISO 27001 and SOC 2.
• Audit-ready by design, with robust encryption, strict access controls, and tamper-proof electronic signatures.
• Electronic informed consent produced by the platform is legally valid and recognised by the FDA, EMA, and other regulatory authorities.

Reported 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 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. Dynamic eCRF automation and real-time consent tracking were implemented for unified data management.
• Phase IV Pediatric 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, and dynamic form behaviours reduced redundant data entry.

oomnia eConsent is deployed as part of Wemedoo's unified SaaS platform, hosted under Swiss data privacy standards. The platform supports multiple concurrent trials on a single instance and is designed for interoperability with other oomnia modules, enabling coordinated management of consent, data capture, patient reporting, and trial master file functions within one system.