Wemedoo

Wemedoo AG is a Swiss health-tech company that develops unified clinical trial software for sponsors, contract research organizations (CROs), and biotech organizations. Its core platform, oomnia, is a clinical research information system that consolidates eight traditionally separate tools — EDC, CTMS, RTSM, eTMF, ePRO, eSource, eConsent, and eCOA — into a single, AI-powered ecosystem. The company is headquartered in Switzerland and operates under Swiss data privacy standards.

Wemedoo serves a broad range of organizations across the clinical research ecosystem, from large biopharma and emerging midsized biotech companies to medical device manufacturers, CROs, clinical trial units, academic institutions, animal health researchers, and consumer health sectors including food, cosmetics, and nutraceuticals. The platform is designed to replace fragmented, disconnected systems with a continuous, structured data flow and to provide real-time trial oversight across all stages of the trial lifecycle.

oomnia Platform — Integrated Modules

• EDC (Electronic Data Capture): Centralized data entry and management for clinical trial data.
• CTMS (Clinical Trial Management System): Planning and operational oversight of trial activities.
• RTSM (Randomization and Trial Supply Management): Automated randomization and supply chain management.
• eTMF (Electronic Trial Master File): Document management and regulatory filing.
• ePRO (Electronic Patient-Reported Outcomes): Direct data capture from study participants.
• eSource: Real-time data capture designed for site operations.
• eConsent: Electronic informed consent workflows for sites and patients.
• eCOA (Electronic Clinical Outcome Assessment): Structured outcome measurement tools integrated within the platform.

Core Capabilities and Performance Metrics

• Trial setup acceleration of up to 83%, based on comparative benchmarks against a major global CRO for a study with 5,000 questions.
• 80–90% faster protocol amendments.
• Up to 90% faster time from last patient, last visit (LPLV) to database lock.
• 100% data standardization, including automated SDTM (Study Data Tabulation Model) mapping.
• Greater than 50% increase in operational efficiency.
• Up to 80% reduction in manual work.
• Real-time trial oversight and automatically updated data across the trial lifecycle.

Customers Served

• Large biopharma: Unified platform to replace multiple disconnected tools and streamline trial oversight.
• Emerging midsized biopharma: Scalable, end-to-end solution supporting rapid study startup with limited resources.
• MedTech: Integrated workflows for device trials and software as a medical device (SaMD), with full regulatory traceability and coverage of pre- and post-market requirements.
• Contract research organizations: Multi-sponsor trial management with centralized oversight, scalable across therapeutic areas and geographies.
• Clinical trial units: eSource, eConsent, and real-time data capture for day-to-day site operations.
• Academia: Free license available for university hospitals and academic research institutions to run studies using enterprise-grade tools.
• Animal health: Veterinary research and development management with visibility across species and regions.
• Food, cosmetics, and nutraceuticals: Clinical-grade data management for consumer health and wellness research.

Compliance and Certifications

• ISO 27001 certified.
• SOC 2 compliant.
• FDA 21 CFR Part 11 compliant.
• GDPR and HIPAA compliant.
• Swiss data privacy standards applied across the platform.

Notable Client Feedback

• James Kuras, Vice President of Clinical Affairs and Operations at Centinel Spine, noted that Wemedoo's technology and engagement in EDC development, site and patient interface, and metric capabilities are distinctive, and that the system adapts to the needs of sponsors, sites, physicians, and study requirements rather than applying a one-size-fits-all approach.
• A representative from Oxular highlighted Wemedoo's cross-functional integrated teams covering EDC setup, go-live, data capture, data cleaning, and data analysis in a globally compliant manner, including support for trials under a US FDA IND. The team's speed of addressing customer needs, affordability, and ability to familiarize US trial sites and CROs with the system were cited as key success factors.

Wemedoo maintains a global network of partners and positions oomnia as a platform adaptable to diverse study designs, therapeutic areas, and geographies. Performance metrics cited by the company are based on internal benchmark analyses, client feedback, and case study data, with the note that results may vary depending on study design and implementation scope.