oomnia CTMS

oomnia CTMS is a clinical trial management system developed by Wemedoo, designed to support the planning, execution, monitoring, and administration of clinical studies from initiation through completion. It operates as part of the broader oomnia platform — a unified SaaS ecosystem that also includes EDC, RTSM, eTMF, eSource, ePRO, eCOA, and eConsent modules — allowing data entered in one module to flow automatically across the system. The CTMS is intended for sponsors, CROs, and site personnel managing single-site or multi-site global trials.

The system is certified under ISO 27001 and SOC 2, and is designed to comply with FDA 21 CFR Part 11, GDPR, and HIPAA requirements. It is hosted under Swiss data privacy standards and supports multiple countries, languages, and regulatory environments. Wemedoo positions the platform as a modular, configurable system where organizations can select the features and modules relevant to their workflows.

Study Planning and Setup

• Site selection and feasibility assessment: Provides tools for evaluating the qualifications and expertise of investigational sites, with real-time reports to support inclusion decisions.
• Investigational site staff tracking: Centralizes contact information for all site staff, and supports monitoring of staff activation, withdrawal, and responsibility management.
• Milestone and enrollment date tracking: Allows teams to define key milestones and planned completion dates at study start, with ongoing tracking and adjustment capabilities.
• Study calendar and Gantt view: Provides a unified view of all completed and upcoming milestones, available in both calendar and Gantt formats.
• Recruitment information: Pulls real-time patient recruitment data directly from the EDC, including statistics on planned, enrolled, screened, and early-terminated patients per site and trial.
• Risk management: Identifies key risk indicators and generates graphical representations, including tracking of missed visits, serious adverse events (SAEs) per subject, and queries per subject.
• Interactive timelines: Organizes monitoring visits and scheduled tasks in a centralized location, with milestone creation and expected completion date tracking.

Study Execution

• Site staff training management: Defines required training for each site staff member and tracks completion status.
• Site delegation management: Ensures appropriate task delegation and training completion per staff member; supports completion of the site staff and delegation log, including sign-offs, within the system.
• Recruitment source tracking: Tracks the recruitment sources for enrolled patients to support optimization of recruitment strategies.
• Integrated messaging and notifications: Supports stakeholder communication via email, in-app messaging, and automated alerts for study milestones, data submissions, and protocol deviations.
• Document sharing and collaboration: Provides document upload, sharing, and collaborative review functionality through the integrated eTMF and CTMS components, including version control, audit trails, and secure access permissions.

Study Monitoring

• Action item log: Enables sending investigational sites information about topics for upcoming monitoring visits or issues identified during previous visits.
• Study visit tracking: Tracks upcoming study visits per participant and generates automatic notifications when a visit occurs outside the expected timeframe.
• Adverse event tracking: Provides real-time access to adverse event data from the EDC, with continuously updated reports and visualizations supporting analysis from occurrence to resolution.
• Protocol deviation tracking: Consolidates all recorded protocol deviations in a single location, with real-time integrated graphical reports to support detection of site-level issues.
• Monitoring visit scheduling and tracking: Allows scheduling of monitoring visits directly in the CTMS, with automatic filing of documentation into the eTMF and automated workflow templates that assign tasks to appropriate users.
• Monitoring visit report creation: Uses predefined templates to generate monitoring visit reports, with the ability to pull data directly from eCRFs and other documents.

Study Administration and Compliance

• Budget creation and management: Provides tools for creating study budgets and predefined budget grids, supporting early cost estimation for visits, examinations, and other trial-related expenses, as well as ongoing financial monitoring.
• Invoice processing and payment tracking: Automates invoice generation based on the number of patients who underwent specific examinations, reducing manual entry for the study team.
• Data privacy and security: Protects sensitive trial data and participant information in compliance with GDPR and HIPAA, with role-based access control restricting document access by user role.
• Audit trails: Records all user actions in a comprehensive audit trail, tracking changes to critical trial data and documents to ensure accountability and data integrity.
• Customizable visualization and dashboards: Offers configurable dashboards, standard templates, and tracking tools that can be adapted to organizational and trial-specific needs.
• Tracking capabilities: Supports automated data integration and visualization from multiple EDC sources, with customizable trackers to support collaboration and workflow management.
• Data export and sharing: Facilitates secure export and sharing of data with external systems or stakeholders while maintaining data integrity.

Complementary Professional Services

• Risk-based monitoring and source data review: Provides oversight, analysis, review, and cleaning of clinical trial data to support data quality, accuracy, and reliability.
• Biostatistics and statistical programming: Covers study design oversight, sample size calculation, randomization solutions, and quantitative interpretation of study results at study close.
• Additional support is available for system implementation, configuration, and alignment with organizational SOPs and workflows.

oomnia CTMS is deployed as a unified SaaS solution, with all modules — including EDC, RTSM, eTMF, eSource, ePRO, eCOA, and eConsent — operating within a single instance supporting multiple concurrent trials. The platform supports multi-site and global trial management with centralized oversight, real-time analytics, and role-based access across all sites and user types.