Adaptive oversight and instant insights with oomnia CTMS

Navigate Clinical Trial Complexities with Confidence and Precision

  • NAll data in one place
  • NEasy data management and tracking
  • NAdverse event monitoring
  • NEfficient budgeting
Adaptive oversight and instant insights with oomnia CTMS
Navigate Clinical Trial Complexities with Confidence and Precision
  • NAll data in one place
  • NEasy data management and tracking
  • NAdverse event monitoring
  • NEfficient budgeting

Explore the capabilities of oomnia CTMS firsthand

oomnia CTMS is an integral part of our unified clinical research software. It automatically incorporates and analyzes data from other oomnia tools (EDC, RTSM, eTMF, ePRO, and eCOA), significantly saving time and money by reducing costly and error-prone manual labour.

Revolutionize trial management with oomnia CTMS

Experience streamlined clinical trial management

oomnia integrates Clinical Trial Management System (CTMS) features designed to streamline and optimize your clinical trial management. CTMS plays a vital role in the planning, execution, monitoring, and reporting of clinical studies. Gain unparalleled insights and oversight across your clinical trials. Trust oomnia for streamlined and data-driven trial management that empowers you to efficiently achieve your research goals.

Illustration shows all oomnia clinical trial software tools.

Benefits of our unified CTMS

Discover the advantages of streamlined trial management

Our unified CTMS is a centralized platform for streamlined trial management. As it is an integral part of our oomnia unified clinical research software it automates previously manual tasks by inherently communicating and updating information from participant eCRFs and other trial-related documents in real time. The result is greater efficiency, accuracy, and timeliness. Experience the ease of managing all aspects of your clinical trial, from study planning to completion, with our software solution, which saves time and money while significantly boosting the accuracy and reliability of your trial data.

Advanced features of oomnia CTMS

Unlock the full potential of your clinical trials

A unified approach to clinical trial management streamlines the entire process, ensuring accuracy and enhanced efficiency across all trial phases. Our oomnia CTMS encompasses a range of features, including the efficient management of data, participants, sites, countries, and documents. Whether you are a clinical data manager, trial director, study coordinator, or clinical research associate, you can benefit from this integrated system, tailored to meet your specific needs throughout the study process.

Reliable site and investigator selection and tracking

Elevate your clinical trials with precision

oomnia CTMS provides features for more efficient site selection, as well as management of sites and researchers during the clinical trial.

Site selection and feasibility assessment

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  • 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

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  • oomnia CTMS enables 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

Study milestone and enrollment management

Efficiently manage study milestones

Our solution enables users to efficiently monitor and manage key milestones and enrollment progress throughout the course of a clinical trial.

Key milestone and enrollment dates tracking

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  • 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

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  • 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

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  • 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.

Comprehensive finance management

Maximize financial control and success

oomnia CTMS helps with budgeting, financial monitoring, and managing expenses associated with clinical trials.

Budget creation and management

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  • oomnia CTMS provides tools for creating a study budget and budget grid, enabling pre-determination of expenses for visits, examinations, and other trial-related costs

Invoice processing and payment tracking

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  • 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

Contract management

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  • With site contract and budget tracking, you can allocate and track amounts for visits, examinations, and other expenses

Cost tracking and analysis

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  • Track actual expenses in real time against the budget, gain insights into cost overruns or savings, and enable proactive financial management

Budget creation and management

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  • oomnia CTMS provides tools for creating a study budget and budget grid, enabling pre-determination of expenses for visits, examinations, and other trial-related costs

Invoice processing and payment tracking

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  • 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

Contract management

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  • With site contract and budget tracking, you can allocate and track amounts for visits, examinations, and other expenses

Cost tracking and analysis

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  • Track actual expenses in real time against the budget, gain insights into cost overruns or savings, and enable proactive financial management

Document management

Streamline and secure your critical documents

Our CTMS solution helps manage essential clinical trial documentation and allows you to easily upload it directly into the eTMF.

Automatic filing to the eTMF

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  • The CTMS allows for the seamless filing of documents directly into the eTMF
  • This feature eliminates the need to download and re-upload documents, thereby saving considerable time

Version control and audit trails

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  • Utilize advanced version control to track document changes and ensure accuracy
  • Maintain transparency with detailed audit trails recording changes, including responsible parties, timestamps, and nature of modifications, providing a comprehensive document revision history

Essential documentation tracking

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  • Keep track of essential documents that have been completed, signed, and filed into the eTMF
  • Set expected dates for document completion and receive notifications about their status

Why oomnia

Integrated EDC, eSource, RTSM, eTMF, ePRO, eCOA, eConsent, and CTMS

All tools provided by oomnia are part of a unified system, supporting multiple trials on a single instance.
  • Unified SaaS-solution
  • Real-time analytics
  • Full interoperability
  • Enhanced usability
  • Easy learning curve
  • Adaptive flexibility
  • Exceptional services
  • Instant collaboration
  • Swift validation process

Training and delegation management

Empower your team for success

oomnia CTMS helps manage necessary study-related training and delegations for each member participating in the clinical trial.

Site staff training management

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  • 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

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  • 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

Monitoring management

Ensure effective oversight and data quality

Our tool helps to manage study-related documents, such as study protocols, informed consent forms and trial reports.

Monitoring visits scheduling and tracking

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  • 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

Action item log

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  • 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

Quick monitoring visit report creation

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  • 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

Easy participant progress tracking

Simplify tracking for efficient progress monitoring

oomnia CTMS allows progress monitoring throughout the study and tracks the recruitment source for each participant.

Study visit tracking

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  • Our oomnia CTMS tracks upcoming study visits for each participant
  • Automatic notifications are generated when a study visit occurs outside the expected timeframe

Recruitment source tracking

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  • The CTMS tracks the recruitment sources for enrolled patients, helping optimize recruitment strategies

Efficient study planning and decision making

Experience smarter study and effective decision-making

oomnia CTMS supports planning and helps make crucial decisions during the course of a clinical trial by providing information on key risk indicators and study milestones.

Risk management

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  • The CTMS can identify key risk indicators and generate graphs to represent them
  • Examples of key risk indicators include the percentage of missed visits, the number of Serious Adverse Events (SAEs) per subject, and the number of queries per subject

Interactive study calendars and timelines

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  • The CTMS helps efficiently organize monitoring visits
  • It displays all scheduled visits and tasks in a centralized location
  • Milestones for the clinical trial can be created within the CTMS, with expected dates set for their achievement

Proud to be a member of cdisc
Since November 2020, we have been a part of the Clinical Data Interchange Standards Consortium. It is our concern to improve the quality and efficiency of clinical research.

Data management and reporting

Unlock insights with efficient data handling

Our solution enables the collection, storage and analysis of study data. It facilitates the creation of reports for internal and external stakeholders, such as regulatory authorities.

Fully customizable visualizations

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  • 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.Tracking possibilities

Data export and sharing capabilities

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  • Our oomnia CTMS facilitates secure export and sharing of data with external systems or stakeholders, while maintaining data integrity

Tracking possibilities

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  • 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

Adverse event and protocol deviation tracking

Ensure safety and protocol adherence

oomnia CTMS enables real-time adverse event and protocol deviation tracking to resolve them as quickly as possible.

Adverse event tracking

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  • oomnia CTMS offers real-time access to detailed information about each adverse event recorded in the EDC
  • It enables continuous tracking of the adverse event until its resolution
  • Regularly updating reports and graphs within the CTMS facilitates the analysis of all adverse events, providing critical safety information

Protocol deviation tracking

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  • 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

Effective communication and collaboration

Facilitate seamless cooperation and information exchange

Our unified software promotes effective communication and collaboration among stakeholders of a clinical trial, including research teams, sponsors, and regulatory authorities.

Integrated messaging and notification system

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  • 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 and collaboration tools

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  • 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

Security and audit trails

Ensure data integrity and compliance

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.

Data privacy and security features

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  • Sensitive trial data and participant information are protected in the CTMS 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

Comprehensive audit trails

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  • 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

SWITCH TO OOMNIA NOW.

Join us on our journey to advance clinical research together.

Complementary services

Unlock more possibilities

Our professional trial services complement your expertise. We support you and enable the implementation of the oomnia CTMS in a manner that aligns with your organization’s workflows and SOPs. These services include risk-based monitoring and statistical programming. We are ready to work hand in hand with your team, as needed.

Risk-based monitoring and source data review

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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 and statistical programming

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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.

See what our clients say

Read more about the experiences from those who have partnered with us

"All jobs, both large and small, are performed with the same dedication to quality, detail, innovative thinking, and rigor. It is always a pleasure to work with the Wemedoo team."

Georg Mathis, PhD

CEO Appeltree CI Group AG

"Wemedoo embodies all the traits desired in a partner in the clinical trial industry – expertise, innovation, reliability, compliance, and attention to detail."
Martina Diminic Smetisko, DMD

Managing Director at Marti Farm Ltd

"Their dedication to, and support of, our projects has resulted in clear quality deliverables. They are always there to answer any questions with expertise in a timely manner. I am looking forward to our next project together."

Volodymyr Stus, MD

Biopharmaceutics and Clinical Research Department Manager at Polpharma SA

Access a detailed CTMS tool overview

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Frequently asked questions

Get the answers you need about oomnia CTMS

What does oomnia Clinical Trial Management System (CTMS) do?

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oomnia CTMS is a comprehensive software solution designed to streamline and optimize the management of clinical trials. It plays a vital role in the planning, execution, monitoring, and reporting of clinical studies. oomnia CTMS is focused on the project management aspects, which can include startup, documents, payments and monitoring of the clinical trial.
Serving as a centralized platform for managing all aspects of clinical trials, oomnia CTMS integrates various trial-related activities and data into a single system, facilitating access and better management.

How does oomnia CTMS enhance clinical trial efficiency?

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If the CTMS is set up correctly from the start, it saves resources over the course of the trial. All the documentation is centrally located and can be accessed with a single click. This has various advantages. First, study staff and contact information is readily available at all times. Furthermore, study milestones are represented in a calendar, and automated notifications are received by the appropriate team members, ensuring timely planning and completion. Budgeting allows the creation and control of the study budget and provides easy oversight of the cost for each visit, examination, and any other item. Lastly, automated workflow templates create tasks for appropriate users as soon as a monitoring visit is scheduled.

What makes our CTMS stand out in the market?

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oomnia CTMS seamlessly incorporates data from other oomnia tools (EDC, RTSM, eTMF, etc.). This drastically increases accuracy, reduces manual labor, and lowers costs. oomnia CTMS can also be used as a standalone system to accommodate data entered by study staff, creating a comprehensive tool to track and manage your clinical trials from site selection to study closeout.

What kind of support and training do we offer for our CTMS?

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In order to gain access and use CTMS tools, users must undergo training. Our oomnia professionals train all system users and are always available to provide comprehensive support. Additionally, we are ready to incorporate your suggestions, implement enhancements, and perform custom work upon request. We work with you at all stages of your trial, whether it is your first or 100th trial.

Can oomnia CTMS help in reducing the overall cost of clinical trials?

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As a part of the oomnia unified clinical research software, our CTMS can significantly reduce the overall costs of your clinical trials. oomnia CTMS is integrally connected with other oomnia systems, such as eCRFs, RTSM, eTMF, ePRO and eCOA, which significantly reduce manual labor and the time lag in making information available to trial management. Automatic real-time reports derived from participant eCRF, PDLs, SAE report forms, and eTMF, among others, provide crucial information regarding trial performance at the participant, investigational site, and trial levels. Performance and risk metrics allow for the timely identification of issues and effective risk mitigation.

How can I book a demo and experience oomnia for myself?

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In order to book a demo call with an oomnia expert, simply click the button below, select a date in the booking tool, and enter all necessary information. We will then send you an invitation.

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As an all-in-one clinical trial software solution, oomnia provides a comprehensive set of tools for efficient clinical trial management. Explore our unified clinical trial solution.