If you are a pharmaceutical company, CRO, academia, medical device manufacturer, or visionary aiming to advance medicine, Wemedoo oomnia is the perfect fit for your clinical trial needs.

The unified oomnia SaaS solution natively includes Electronic Data Capture (EDC), Randomization & Trial Supply Management (RTSM), Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF), electronic Patient Reported Outcomes (ePRO), electronic Clinical Outcome Assessment (eCOA), eConsent, and eSource and allows real-time access to data and analytics across all tools, systems, and organizations.

Get real-time oversight, highest data quality, and reach your goals faster than ever.

EDC & RTSM

Our EDC is integrated with RTSM, laboratory management, SAE report forms, protocol deviation logs, and others and enables the creation of any form type. Data integration capabilities, customized dashboards, and real-time reports help to oversee and manage clinical trials effectively. With user-friendly configuration, controlled user access, and data integration, oomnia EDC is the best in the business.

Our RTSM offers comprehensive features that revolutionize randomization, allocation to treatment, and trial supply management. As part of a unified system, it automatically communicates with other modules enabling randomization and allocation to treatment directly within the eCRF.

Advanced Features

- ACCURATE DATA CAPTURE: Capture accurate patient data at the point of care.
- DATA VALIDATION AND AUDIT TRAILS: Ensure data quality with real-time validation, automated cleaning, and audit trails.
- INTUITIVE USER INTERFACE: Enhance user experience, simplifying data entry and navigation while reducing training time.
- DATA SECURITY AND PROTECTION: Safeguard trial information with encryption, strict access controls, regular assessments, and robust backups.
- REAL-TIME DATA ACCESS AND MONITORING: Gain fast insights with real-time data access, live visualization, remote monitoring, and data synchronization.
- DATA EVALUATION AND REPORTING: Elevate data insights with graphical reports, automated validation, customizable reporting, and flexible data export options.
- RANDOMIZATION: Transform trials with automated randomization, stratification, and treatment allocation for unbiased designs.
- MANAGEMENT OF STUDY MEDICATION AND MATERIALS: Simplify logistics with real-time tracking, inventory management, reorder triggers, and expiration monitoring.
- BLINDING: Ensure trial integrity with secure blinding, controlled access, and automatic tracking.
- DATA INTEGRATION AND REPORTING: Achieve seamless data flow with centralized access, customizable reporting, real-time updates, and export capabilities.

Benefits

- PROTOCOL ADHERENCE: Streamline protocol deviation management and enhance adherence with centralized tracking and easy generation of deviations.
- DATA QUALITY: Minimize data entry errors and ensure data integrity with real-time validation checks, audit trails, and data tracking.
- DATA COLLECTION: Reduce manual data entry errors, speed up data capture and analysis with automated EDC forms and customizable reporting.
- ACCESSIBILITY: Access RTMS seamlessly with a single login for all activities for users with eCRF access.
- REAL-TIME REPORTING: Get real-time insights into IMP status and location and prevent delays with automated low-stock notifications.
- RESOURCE MANAGEMENT: Streamline IMP distribution, optimize inventory, and ensure timely kit delivery with real-time tracking and task automation.
- ERROR REDUCTION: Reduce data entry errors and manual queries by up to 67%. Minimize reconciliation and ensure proper IMP allocation with integrated RTSM and eCRF.
- TIME SAVINGS: Enhance efficiency and accelerate trial management with interoperable tools and real-time reporting. Set up, deploy, and validate eCRFs in weeks, minimizing future issues and time needed to lock the database with data validation checks.
- COST SAVINGS: Save up to 67% of CRAs' time on query resolution, streamline EDC form development, and reduce labor costs by automatically allocating kits nearing expiration to prevent wastage.

Compliance With

- ICH GCP E6
- Good Clinical Data Management Practices, edition 4 (GCDMP)
- Good Automated Manufacturing Practice, edition 5 (GAMP 5)
- FDA 21 CFR Part 820
- FDA 21 CFR Part 11
- Declaration of Helsinki
- ISO 9001:2015 standard
- ISO 27001:2022 standard
- EudraLex, vol. 2 and 4
- GDPR, FADP, and HIPAA

The next step in advancing your clinical research is with us.

Wemedoo oomnia EDC & RTSMWemedoo AG

Wemedoo oomnia EDC & RTSM

Wemedoo AG

Wemedoo oomnia EDC & RTSM

Wemedoo AG

Wemedoo oomnia EDC & RTSM
Wemedoo AG