Achieve streamlined processes, real-time insights, and significant time and cost savings from study initiation to completion.
Why Choose oomnia's CTMS?
Unified System, Real-Time Results
Once data is entered, it immediately flows across all modules of oomnia. This built-in seamless interoperability eliminates errors, ensures audit readiness, and delivers instant analysis-ready insights.
Flexible & Modular by Design
oomnia's modular flexibility lets the CTMS adapt in real-time to your evolving trial needs. Each feature is part of one unified system, removing the complexity and costs associated with integration.
Instant Collaboration, Oversight & Insights
Collaborate instantly across teams and sites with live updates and full visibility into trial progress. oomnia real-time insights help you stay in control, act faster and manage trials more effectively.
Intelligent Automation, Clinical Knowledge
Combine deep clinical expertise with advanced technologies like AI and LLMs to automate what matters most. Smart automation reduces manual work, increases accuracy, and cuts costs and timelines by up to 80%.
Save Up to 80% in Time & Costs
Get faster execution, lower overhead, and better results.
oomnia CTMS includes a feature for assessing the qualifications and expertise of trial sites. Real-time reports offer insights, aiding in the decision-making process about the inclusion of new investigational sites in the clinical trial.
List of Investigational Site Staff
We enable centralized tracking of all site staff involved in the clinical trial, consolidating their contact information in a single location. The tool allows for the monitoring of site staff activation and withdrawal, as well as the management of their responsibilities.
Key Milestone & Enrollment Dates Tracking
Our CTMS enables defining key milestones and scheduling planned completion dates at the start of the clinical trial. It ensures these milestones are tracked and met within set timelines, allowing for adjustments if needed.
All Milestones in One Place
oomnia CTMS provides a clear overview of all completed and forthcoming milestones in the study calendar. It offers various viewing options, including calendar view and Gantt view, to efficiently monitor trial progress.
Recruitment Information
The CTMS enables real-time tracking of the latest patient recruitment information, sourced directly from the EDC. It provides detailed statistics on the number of planned, enrolled, screened, or early-terminated patients for each clinical trial and investigational site.
Risk Management
The CTMS can identify key risk indicators and generate graphs to represent them. Examples include tracking the percentage of missed visits, monitoring Serious Adverse Events (SAEs) per subject, and analyzing the number of queries per subject.
Interactive Study Calendars & Timelines
The CTMS efficiently organizes monitoring visits and displays all scheduled visits/tasks in a centralized location. Users can create clinical trial milestones with expected completion dates, enabling proactive timeline management.
Study Execution
Site Staff Training Management
Our CTMS tool allows defining the required training for each site staff member. It facilitates tracking of the completion status of these trainings.
Site Delegation Management
Ensure that each site staff member is delegated the appropriate tasks and has completed the necessary training. Complete the site staff and delegation log, including sign-offs, directly within oomnia.
Recruitment Source Tracking
The CTMS tracks the recruitment sources for enrolled patients, helping optimize recruitment strategies.
Integrated Messaging & Notification System
Seamless stakeholder communication in the CTMS is supported by features such as email, in-app messaging, and automated alerts. Timely notifications and alerts enhance collaboration by addressing study milestones, data submissions, and protocol deviations.
Document Sharing & Collaboration Tools
The eTMF and CTMS components offer functionalities for document upload, sharing, and collaborative review. These tools include features such as version control, audit trails, and secure access permissions. These systems simplify contact list management for effective communication and collaboration.
Up To
83%
Faster Trial Setup Client trial set up with 5000 questions compared to time needed by one of the biggest global CROs for the same trial in a different geography
100%
Real-Time Trial Oversight
100%
Client Retention
Study Monitoring
Action Item Log
The CTMS provides the capability to send investigational sites information about topics to be discussed during the upcoming monitoring visit or issues identified during the previous visit.
Study Visit Tracking
Our oomnia CTMS tracks upcoming study visits for each participant. Automatic notifications are generated when a study visit occurs outside the expected timeframe.
Adverse Event Tracking
oomnia CTMS offers real-time access to detailed information about each adverse event recorded in the EDC, enabling continuous tracking from occurrence to resolution. Regularly updated reports and visualizations within the CTMS support the comprehensive analysis of all adverse events, providing critical safety information.
Protocol Deviation Tracking
The CTMS consolidates all recorded protocol deviations in a single location, easily accessible. It supports necessary mitigation steps with real-time integrated graphical reports, enabling the detection of issues at investigational sites.
Monitoring Visits Scheduling & Tracking
Monitoring visits can be scheduled directly through the CTMS. The system automatically files information and essential documentation into the eTMF. Automated workflow templates can be set up in the CTMS to create tasks for the appropriate users.
Quick Monitoring Visit Report Creation
Predefined templates in the CTMS allow for the quick creation of monitoring visit reports. The tool enables pulling information directly from eCRFs and other documents for comprehensive reporting.
Case Studies, Our Proof of Expertise
Ophthalmology Medical Device & Drug Study
Streamlined Study & eCRF Implementation: Managed a complex study with 5000+ CRF questions and dynamic eCRF features that reduced manual queries by 66%.
Rapid Execution & Training: Completed design, implementation, UAT, and site training in just 9 weeks, ensuring a smooth go-live.
Accelerated Study Timelines: Achieved database lock within 2 weeks after the last patient’s visit, significantly speeding up the study.
Medical Device Real-World Evidence Study
Holistic Study Design: Integrated retrospective data collection and prospective ePRO arms, with expert protocol development.
Seamless Digital Integration: Leveraged oomnia EDC, eConsent, and ePRO to streamline data collection, consent, and patient engagement.
Automated Workflows & Unified Data: Implemented dynamic eCRF automation and real-time consent tracking with integrated data management for flawless protocol oversight.
Automated Oversight for a Phase IV Pediatric Study
Comprehensive & Real-Time PD Tracking: Developed a robust log capturing all protocol deviations in detail, with real-time reports by country, site, and participant.
Automated Role-Based Alerts: Implemented automatic email notifications that alert designated roles for timely review and approval.
Streamlined Data Entry & Resolution: Dynamic behaviors reduce redundant questions and dramatically cut the time needed to track, review, and resolve deviations.
Study Administration & Compliance
Budget creation and management
oomnia CTMS provides tools for creating study budgets and predefined budget grids, enabling early estimation of expenses for visits, examinations, and other trial-related costs. It supports financial monitoring and efficient expense management throughout clinical trials.
Data Privacy & Security Features
Sensitive trial data and participant information are protected in compliance with global data protection regulations, such as GDPR and HIPAA. Role-based access control is implemented within the system to restrict document access, ensuring data privacy and regulatory compliance.
Fully Customizable Visualization
The CTMS offers customization options to align with the specific needs and preferences of your organization and/or trial. It provides flexibility for full personalization, including the use of standard templates and dashboards.
Invoice Processing & Payment Tracking
Our CTMS tool streamlines the process of invoice creation during the clinical trial with its efficient invoice entry feature. The study team only needs to input the number of patients who underwent specific examinations, and the system will automatically generate an invoice.
Tracking Possibilities
Automated data integration and visualization from multiple EDC sources within the CTMS optimize data analysis efficiency. Customizable trackers in the CTMS enhance collaboration, streamline workflows, and improve overall study quality.
Security & Audit Trails
Users in oomnia CTMS will only be able to access features and documents for which they have appropriate permissions, and all actions are recorded in the audit trail, providing a comprehensive overview of activities performed in the system.
Comprehensive Audit Trails
Detailed logs of user actions are maintained in the CTMS to ensure system accountability. Tracking changes in critical trial data and documents within the system ensures accountability and data integrity.
Data Export & Sharing Capabilities
Our oomnia CTMS facilitates secure export and sharing of data with external systems or stakeholders, while maintaining data integrity.
Inspired by the Latin Word omnia, Meaning 'All Things',
We Created oomnia.
A single, unified system that brings together every part of a clinical
trial, from planning to global compliance.
EDC, RTSM, eTMF and CTMS, eSource, ePRO, eCOA and eConsent are
integrative parts of one and the same ecosystem supporting multiple
trials on a single instance.
Choose the modules and features that work for you and customize
everything to fit your workflow.
Our professional services are here to strengthen your team and ensure oomnia CTMS fits seamlessly into your workflows and SOPs. From implementation and configuration to risk-based monitoring and statistical programming, we work alongside you to deliver faster, and smoother trials.
Risk-Based Monitoring & Source Data Review
Our service is dedicated to ensure the highest quality, accuracy, validity, and reliability of your clinical trial data. The service encompasses thorough oversight, sophisticated analysis, review, and cleaning of clinical trial data. Discover our Risk-Based Monitoring and Source Data Review service.
Biostatistics & Statistical Programming
Before the study’s commencement, biostatistical methods are used to oversee the study design, to calculate the sample size, and to provide randomization solutions for a scientifically sound study design. As the data collection is completed and the clinical study brought to a close, biostatistics provides a quantitative framework for interpreting the study results. Learn more about our Biostatistics and Statistical Programming service.
What is CTMS software, and what does oomnia CTMS do?
A Clinical Trial Management System (CTMS) is a comprehensive software solution used to plan, execute, and monitor clinical trials. Wemedoo's oomnia CTMS acts as a centralized platform that manages all project management aspects of a study. It plays a vital role in study startup, site management, enrollment tracking, document handling, payments, milestone monitoring, risk management, and regulatory compliance from study initiation through completion.
What are the key features of oomnia CTMS software?
oomnia CTMS equips study teams with a complete suite of tools within one unified clinical trial system. Key features include: Study Planning & Setup with streamlined tools for site selection and feasibility assessments; Tracking & Dashboards with interactive study calendars, enrollment tracking, and milestone monitoring; Risk & Financial Management with risk management dashboards, budgeting tools, and comprehensive financial tracking; Investigational Product (IP) Tracking for easy oversight of trial supplies; and Automated Workflows with templates that instantly create tasks for appropriate users as soon as a monitoring visit is scheduled.
Can oomnia CTMS manage multi-site and global clinical trials?
Yes, oomnia CTMS is purpose-built for multi-site and global trial management. It seamlessly supports multiple countries, languages, and complex regulatory environments. Sponsors, CROs, and site personnel benefit from real-time oversight across all sites, centralized milestone tracking, and secure, role-based access.
How does oomnia CTMS differ from standalone CTMS solutions in the market?
What makes oomnia CTMS stand out is its native unification. Unlike standalone CTMS solutions that require costly, time-consuming integrations with separate systems, oomnia seamlessly incorporates data from other oomnia tools—such as EDC, RTSM, ePRO, eCOA, and eTMF. Enrollment data from the EDC, documents from the eTMF, and randomization data from RTSM automatically flow into the CTMS. This eliminates manual data entry, prevents reconciliation errors, drastically increases accuracy, and lowers costs. (Note: oomnia CTMS can also be deployed as a highly effective standalone system if preferred).
How does oomnia CTMS enhance clinical trial efficiency?
If set up correctly from the start, oomnia CTMS saves massive resources over the course of a trial by providing single-click access to centrally located documentation and study staff contact information, utilizing interactive study calendars that trigger automated notifications to appropriate team members, automating workflow templates for site monitoring and task delegation, and ensuring timely planning and completion of all study milestones.
Can oomnia CTMS help in reducing the overall cost of clinical trials?
Absolutely. As part of the oomnia unified clinical research software, our CTMS significantly reduces overall study costs. By integrally connecting with eCRFs, RTSM, eTMF, and other systems, it reduces manual labor and eliminates the time lag in making data available to trial management. Automatic, real-time reports derived from participant eCRFs, Protocol Deviations (PDLs), and Serious Adverse Event (SAE) reports allow for the timely identification of issues and effective risk mitigation—preventing costly delays.
What reporting and analytics capabilities does oomnia CTMS provide?
Data visibility is critical for trial success. oomnia CTMS provides comprehensive, real-time reporting dashboards that feature customizable Key Performance Indicators (KPIs), enrollment metrics and site performance analytics, risk indicators and protocol deviation tracking, and budget oversight and financial reporting. Reports can be generated automatically and shared securely with all stakeholders through the unified system.
Is oomnia CTMS compliant with global regulatory standards?
Yes. Wemedoo ensures that oomnia CTMS is built to meet stringent global regulatory requirements, including FDA 21 CFR Part 11, GDPR, and HIPAA. It includes comprehensive audit trails, electronic signatures, and strict role-based access controls to ensure your trial data remains secure, compliant, and inspection-ready at all times.
What kind of support and training do you offer for your CTMS?
We ensure your team is set up for success from day one. To gain access, users undergo specialized training led by our oomnia professionals. Furthermore, our team provides comprehensive, ongoing support. We partner with you at all stages of your trial—whether it is your 1st or your 100th—and are always ready to incorporate your suggestions, implement enhancements, or perform custom development work upon request.
How can I book a demo and experience oomnia for myself?
Experiencing the power of oomnia CTMS is easy. Simply click the “Book a Demo” button below, select a date and time that works for you in our booking tool, and enter your basic information. An oomnia expert will send you an invitation to explore the platform tailored to your specific trial needs.
