Interoperable Clinical Trial Software Tools

oomnia is a unified Clinical Research Information System (CRIS) that includes eight fully interoperable modules: Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), Randomization and Trial Supply Management (RTSM), electronic Informed Consent (eConsent), electronic Patient-Reported Outcomes (ePRO), electronic Clinical Outcome Assessments (eCOA), and eSource Data Capture. All modules share a single database and user interface, eliminating data silos and manual reconciliation.

Unlike fragmented systems that require complex integrations, all oomnia modules operate natively on a single, unified database. This means data captured in one module (e.g., EDC) is instantly available across all others (e.g., CTMS, eTMF) in real time. oomnia also supports FHIR HL7 for external system integration and generates CDISC-compliant datasets (SDTM, ADaM, Define.XML) for seamless regulatory submissions.

Yes. oomnia is fully compliant with 21 CFR Part 11, EU Annex 11, ICH GCP (E6 R2/R3), HIPAA, GDPR, and the Swiss Data Privacy Law. Wemedoo is ISO 27001 and ISO 9001 certified, has been inspected by the FDA and Swiss Medic with zero findings, and follows ALCOA+ data integrity principles. All clinical data is protected with AES-256 encryption, complete audit trails, and role-based access controls.

Yes. oomnia's modular architecture allows you to deploy only the tools you need, whether that is EDC alone, EDC with RTSM, or the full suite. Each module works independently while maintaining the ability to share data seamlessly when combined. This flexibility allows organizations to adopt oomnia incrementally and scale as their trial needs evolve.

oomnia enables up to 83% faster trial setup compared to legacy CRO systems. This is achieved through intelligent eCRF form builders, auto-validating databases, reusable templates, and a unified architecture that eliminates the need to configure and integrate separate systems. Mid-study protocol amendments can also be implemented rapidly without disrupting live data collection.

oomnia supports all types and phases of clinical trials, including interventional trials (Phase I–IV), observational studies, decentralized clinical trials (DCTs), medical device trials, real-world data studies, and academic research. The platform is used by pharmaceutical sponsors, biotechnology companies, Contract Research Organizations (CROs), hospitals, and academic institutions across more than 25 countries.

Clinical data security is foundational to oomnia. All data is encrypted at rest and in transit using AES-256 encryption. The platform includes comprehensive audit trails, role-based access controls, and real-time security monitoring. Wemedoo is ISO 27001 certified, SOC 2 compliant, and adheres to GDPR, HIPAA, and Swiss data protection regulations. The platform is hosted on secure, redundant cloud infrastructure with 99.9% uptime.

Yes. Because all oomnia modules share a single database, every data point is available in real time across the entire platform. Sponsors, CROs, and site staff can access live dashboards, generate on-demand reports, and monitor trial performance metrics without waiting for data transfers, reconciliation, or manual exports. This provides 100% real-time trial oversight from day one.

oomnia is a true Clinical Research Information System, not a collection of integrated point solutions. All eight modules operate from a single codebase and database, delivering native interoperability without middleware or API bridges. This unified architecture reduces costs, eliminates data reconciliation, accelerates timelines, and provides a single source of truth for all stakeholders. Wemedoo was recognized with the SCDM Innovation Award 2025 for this approach.

Yes. Wemedoo offers a free oomnia license for academic and university research institutions. Academic researchers receive full access to the unified platform for non-commercial clinical studies, enabling them to benefit from the same enterprise-grade tools used by pharmaceutical sponsors and CROs without licensing costs.