OOMNIA – THE FIRST TRUE ALL-IN-ONE CLINICAL TRIAL SOFTWARE

  • NComprehensive digital trial workflows
  • NFully interoperable
  • NAdvanced data analytics
  • NReal-time trial monitoring and alerts
  • NRegulatory compliant
OOMNIA – THE FIRST TRUE ALL-IN-ONE CLINICAL TRIAL SOFTWARE
  • NComprehensive digital trial workflows
  • NFully interoperable
  • NAdvanced data analytics
  • NReal-time trial monitoring and alerts
  • NRegulatory compliant

The future of clinical trial management

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Imagine a world where every step of your clinical trial, from planning to execution, is not just manageable but thrives on efficiency and simplicity. That’s the world oomnia creates, supporting pharmaceutical companies, CROs, academia, medical device manufacturers, international organizations, and all visionaries aiming to advance medicine, regardless of trial type or focus.

The unified oomnia SaaS solution natively includes EDC, eSource, RTSM, eTMFePRO, eCOA, eConsent, and CTMS and allows real-time access to data and analytics across all tools, systems, and organizations.

Dive into a seamless experience where real-time data insights and expert support are at your fingertips. Embrace simplicity in clinical trials and discover a journey marked by clear, effortless progress.

oomnia is your partner in achieving unparalleled efficiency and accuracy. It ensures that your clinical projects move swiftly, without compromising quality or compliance, leading to successful outcomes faster than ever before.

Experience the Difference
oomnia elevates your team, optimizes workflows, and unleashes the full power of your clinical endeavors. Be part of the revolution that is reshaping clinical research.

Your benefits

From today's gains to tomorrow's breakthroughs with oomnia

oomnia unlocks a universe of potential that extends well beyond the immediate benefits we have outlined here. We see them as dynamic catalysts, driving clinical research into a boundless horizon of future opportunities. Discover how these initial steps lay the groundwork for future accomplishments.

Instant data quality

Near 100% upon data entry already

oomnia elevates clinical trial quality through precise data management, advanced analytics, and streamlined, error-reducing processes.

Save time

Time savings more than 50%

oomnia saves time in clinical trials by automating workflows, reducing reconciliations, and simplifying complex research processes.

Profit from lower costs

Cost reduction more than 50%

oomnia reduces clinical trial costs by streamlining processes, transparency in reporting and analytics, and minimizing the need for multiple costly systems and trainings.

All metrics calculations based on data received from our clients.

Unified EDC, eSOURCE, RTSM, eTMF, ePRO, eCOA, eCONSENT and CTMS

  • Unified SaaS-solution
  • Real-time analytics
  • Full interoperability
  • Unmatched user experience
  • Easy learning curve
  • Adaptive flexibility
  • Exceptional services
  • Instant collaboration
  • Swift validation process
Best Scientific Abstract Award – World Cancer Congress 2024
Our founder, Nikola Cihoric, as the senior scientist, along with his colleagues, has been nominated for the Best Scientific Abstract at World Cancer Congress 2024.

oomnia features

Explore the power of oomnia

Get familiar with oomnia features that shift the paradigm in clinical research.

All-in-one software solution

All clinical trial tools are integrative parts of one cohesive system. You learn, collaborate, and report in real time.

Professional assistance

You need less than a day to get familiar with oomnia. If there are any questions we are here for you and your team 24/7.

True
interoperability

oomnia is fully interoperable with other systems. Import and export your data whenever you want and choose your preferred format.

Infinite trial types supported

Conduct all types of trials with ease – hybrid, decentralized, synthetic, real-world data or medical devices.

L

The phase of implementation lays the groundwork for a clinical trial. It encompasses the crucial steps of planning, designing, setting up, and ensuring access. This phase is characterized by meticulous preparation, where trial objectives and methodologies are defined, trial sites are selected, staff are recruited and trained, and regulatory approvals are obtained. It’s a phase of strategic planning and logistical arrangement, ensuring that the trial is poised for success with a solid foundation and clear access paths for participants.

L

The conduct phase is where the clinical trial itself comes into action. This phase includes enrolling participants, collecting data, and monitoring the trial’s progress. It is especially marked by active engagement with participants, where their data is collected and analyzed to assess the efficacy and safety of the intervention. Continuous monitoring ensures the trial adheres to its protocols and maintains high ethical and safety standards. The success of this phase is crucial as it directly impacts the reliability and validity of the trial results.

L

In the closure phase, the trial begins to wind down. This phase involves closing the trial sites, ensuring all data collection is finalized, analyzing the gathered data, decommissioning the trial infrastructure, and formally ending the trial. It is a period of reflection and conclusion, where the results are synthesized and prepared for reporting. The closure phase ensures a responsible and comprehensive wrap-up of the trial, paving the way for marketing authorization and improved patient outcomes.

L

The lessons learned phase is an opportunity for evaluation of processes and technology after the trial has concluded. It focuses on analyzing the successes and shortcomings to improve future research. This phase involves a thorough review of the entire trial process, identifying best practices, and considering stakeholder feedback. It culminates in scaling the successful elements of the trial, applying the lessons learned to broader contexts, and influencing future practices and processes. This phase is vital for the continuous improvement of clinical research methodologies and their application in real-world scenarios.

L

The planning and design step is the first and most important step of any clinical trial process. During this step and the overall implementation phase, data management and biostatistical teams, aid in defining study objectives and endpoints, perform the sample size calculations, create the randomization schedule, analyze the trial design, and design the data collection instruments. Additionally, regulatory documents supporting trial processes are written by experts. These steps are performed so that the study can meet its endpoints, and to ensure the validity and reliability of the trial results.

L

The set-up step is a critical moment when the clinical trial infrastructure is implemented. This includes the creation of the trial organization structure, implementing the eCRF and other data collection instruments, as well as randomization schedules, and the eTMF structure. Training staff and writing all user manuals and instructions must be completed for the trial to run smoothly. Regulatory documents and plans supporting trial processes are written by experts so that trial conduct is documented for all staff. This step ensures that the trial is conducted efficiently and is in compliance with all guidelines and regulations.

L

In the step of access, the focus is on ensuring that all trial staff have appropriate access to the digital tools they need to perform their tasks. This means giving them access to the oomnia system with the eCRF, or other EDC documents, as well as modules they need. This can be the RTSM or eTMF. It is important that the organizational structure created in step 2 is tested well so that site and CRO staff only receive access to data from organizations to which they are allowed access. Enhanced security measures such as two-factor authentication is also set at this point.

L

The first step of the trial conduct phase is when participants are actively recruited and enrolled into the trial. Using a unified system, this means that the investigational medicinal product (IMP) must be sent to and received by sites and the events be logged in the trial management system. As the randomization schedule has been uploaded and auto-detection of strata has been set, with the integrated RTSM and eCRF study staff enroll trial participants, allocate them to treatment, and stratify them with only one click.

L

Accurate and consistent data collection is crucial for the validity of the trial results. In the step of data collection, researchers systematically capture data via the eCRF or other EDC documents as per the trial protocol. A unified system allows for the collection of eCRF data, protocol deviations, SAE report forms, as well as eTMF documents. By eliminating the need for the use of disparate systems, data transfer, copy pasting or data input into multiple systems, a unified system like oomnia helps to ensure data quality and integrity while reducing workload.

L

Monitoring a clinical trial involves far more than source data verification (SDV). With a unified system and almost unlimited analytics capabilities, trial monitoring and oversight takes a new form. Performance of SDV, medical review and data management review can be tracked and followed by all parties in real time. Integrated reports can be used to track monitoring visits, actions recorded in the CTMS, eTMF completion, and much more. Real-time statistical analyses enable risk-based monitoring and the visualization of site performance and comparisons. Prompt identification of issues to ensure trial integrity and participant safety is simple.

L

For participants, this steps marks the end of the active stage of the trial. It involves ensuring all data collection is complete and accurate. All SDV must be performed, as well as medical review of the data. Access to the database is highly restricted to ensure only data which is necessary to be updated is changed. Proper lock and closure is essential for statistical analyses.

L

Analysis is a critical step where collected data is systematically examined to draw conclusions about the trial’s outcomes. This involves statistical analysis to assess the efficacy and safety of the intervention, interpreting results, and preparing the final reports. The accuracy and rigor of this step are crucial for the reliability of trial outcomes.

L

Decommissioning of the digital trial infrastructure occurs after all statistical analyses have been completed and access to EDC documents and modules is no longer required by any trial staff. All documentation must be finalized and any unused materials and IMP must be disposed of or returned. All digital documents must have been transferred to the sponsor, and access to the trial is revoked for all staff. Checks involved in this step ensures that all aspects of the trial are concluded responsibly and in compliance with regulatory requirements.

L

The step of improvement focuses on lessons learned from the trial. This involves analyzing what worked well and what did not, identifying best practices, and considering feedback from all stakeholders. The insights gained are used to refine processes, improve trial designs and the software, and enhance future clinical research practices.

L

Scaling involves applying the successful strategies and lessons learned from the trial to broader contexts. This may include creating templates for future trials and  adapting its methodologies for future projects. Successful scaling maximizes the improvements and efficiencies in future projects, and contributes to accelerated drug discovery and improved patient outcomes.

Implementation

:
;

The phase of implementation lays the groundwork for a clinical trial. It encompasses the crucial steps of planning, designing, setting up, and ensuring access. This phase is characterized by meticulous preparation, where trial objectives and methodologies are defined, trial sites are selected, staff are recruited and trained, and regulatory approvals are obtained. It's a phase of strategic planning and logistical arrangement, ensuring that the trial is poised for success with a solid foundation and clear access paths for participants.

Plan & Design

:
;

The planning and design step is the first and most important step of any clinical trial process. During this step and the overall implementation phase, data management and biostatistical teams, aid in defining study objectives and endpoints, perform the sample size calculations, create the randomization schedule, analyze the trial design, and design the data collection instruments. Additionally, regulatory documents supporting trial processes are written by experts. These steps are performed so that the study can meet its endpoints, and to ensure the validity and reliability of the trial results.

Set-Up

:
;

The set-up step is a critical moment when the clinical trial infrastructure is implemented. This includes the creation of the trial organization structure, implementing the eCRF and other data collection instruments, as well as randomization schedules, and the eTMF structure. Training staff and writing all user manuals and instructions must be completed for the trial to run smoothly. Regulatory documents and plans supporting trial processes are written by experts so that trial conduct is documented for all staff. This step ensures that the trial is conducted efficiently and is in compliance with all guidelines and regulations.

Access

:
;

In the step of access, the focus is on ensuring that all trial staff have appropriate access to the digital tools they need to perform their tasks. This means giving them access to the oomnia system with the eCRF, or other EDC documents, as well as modules they need. This can be the RTSM or eTMF. It is important that the organizational structure created in step 2 is tested well so that site and CRO staff only receive access to data from organizations to which they are allowed access. Enhanced security measures such as two-factor authentication is also set at this point.

Conduct

:
;

The conduct phase is where the clinical trial itself comes into action. This phase includes enrolling participants, collecting data, and monitoring the trial's progress. It is especially marked by active engagement with participants, where their data is collected and analyzed to assess the efficacy and safety of the intervention. Continuous monitoring ensures the trial adheres to its protocols and maintains high ethical and safety standards. The success of this phase is crucial as it directly impacts the reliability and validity of the trial results.

Enroll

:
;

The first step of the trial conduct phase is when participants are actively recruited and enrolled into the trial. Using a unified system, this means that the investigational medicinal product (IMP) must be sent to and received by sites and the events be logged in the trial management system. As the randomization schedule has been uploaded and auto-detection of strata has been set, with the integrated RTSM and eCRF study staff enroll trial participants, allocate them to treatment, and stratify them with only one click.

Collect

:
;

Accurate and consistent data collection is crucial for the validity of the trial results. In the step of data collection, researchers systematically capture data via the eCRF or other EDC documents as per the trial protocol. A unified system allows for the collection of eCRF data, protocol deviations, SAE report forms, as well as eTMF documents. By eliminating the need for the use of disparate systems, data transfer, copy pasting or data input into multiple systems, a unified system like oomnia helps to ensure data quality and integrity while reducing workload.

Monitor

:
;

Monitoring a clinical trial involves far more than source data verification (SDV). With a unified system and almost unlimited analytics capabilities, trial monitoring and oversight takes a new form. Performance of SDV, medical review and data management review can be tracked and followed by all parties in real time. Integrated reports can be used to track monitoring visits, actions recorded in the CTMS, eTMF completion, and much more. Real-time statistical analyses enable risk-based monitoring and the visualization of site performance and comparisons. Prompt identification of issues to ensure trial integrity and participant safety is simple.

Closure

:
;

In the closure phase, the trial begins to wind down. This phase involves closing the trial sites, ensuring all data collection is finalized, analyzing the gathered data, decommissioning the trial infrastructure, and formally ending the trial. It is a period of reflection and conclusion, where the results are synthesized and prepared for reporting. The closure phase ensures a responsible and comprehensive wrap-up of the trial, paving the way for marketing authorization and improved patient outcomes.

Close

:
;

For participants, this steps marks the end of the active stage of the trial. It involves ensuring all data collection is complete and accurate. All SDV must be performed, as well as medical review of the data. Access to the database is highly restricted to ensure only data which is necessary to be updated is changed. Proper lock and closure is essential for statistical analyses.

Analyze

:
;

Analysis is a critical step where collected data is systematically examined to draw conclusions about the trial's outcomes. This involves statistical analysis to assess the efficacy and safety of the intervention, interpreting results, and preparing the final reports. The accuracy and rigor of this step are crucial for the reliability of trial outcomes.

Decommission

:
;

Decommissioning of the digital trial infrastructure occurs after all statistical analyses have been completed and access to EDC documents and modules is no longer required by any trial staff. All documentation must be finalized and any unused materials and IMP must be disposed of or returned. All digital documents must have been transferred to the sponsor, and access to the trial is revoked for all staff. Checks involved in this step ensures that all aspects of the trial are concluded responsibly and in compliance with regulatory requirements.

Lessons Learned

:
;

The lessons learned phase is an opportunity for evaluation of processes and technology after the trial has concluded. It focuses on analyzing the successes and shortcomings to improve future research. This phase involves a thorough review of the entire trial process, identifying best practices, and considering stakeholder feedback. It culminates in scaling the successful elements of the trial, applying the lessons learned to broader contexts, and influencing future practices and processes. This phase is vital for the continuous improvement of clinical research methodologies and their application in real-world scenarios.

Improve

:
;

The step of improvement focuses on lessons learned from the trial. This involves analyzing what worked well and what did not, identifying best practices, and considering feedback from all stakeholders. The insights gained are used to refine processes, improve trial designs and the software, and enhance future clinical research practices.

Scale

:
;

Scaling involves applying the successful strategies and lessons learned from the trial to broader contexts. This may include creating templates for future trials and adapting its methodologies for future projects. Successful scaling maximizes the improvements and efficiencies in future projects, and contributes to accelerated drug discovery and improved patient outcomes.

Access from everywhere

Access it from anywhere, work offline and upload later, use any device and collaborate whenever you want.

User-friendly interface

Intuitive and simple user interface, no coding skills required, and drag-and-drop functionalities allow even complex settings.

Real-time
reporting

Once data is captured in oomnia, it is primed for analysis. Gain instant insights with on-the-fly metrics tailored to your needs.

Infinite trial scalability

Effortlessly oversee all your trials in real time, add an unlimited number of patients, users, and sites. Use oomnia to learn, develop, and stay ahead of competition.

EXPERIENCE OUR EASY-TO-USE INTERFACE

Professional trial tools

oomnia unifies clinical trial tools in one software

Get permanent access to all your data across all tools and collaborate in real time.
Illustration shows all oomnia clinical trial software tools.

EDC/eCRF

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Precision in data management
Within oomnia, our Electronic Data Capture (EDC) tool offers comprehensive capabilities, including user-friendly configuration, controlled user access, and data integration and processing. This integration extends to IMP randomization directly within the electronic Case Report Form (eCRF) document, streamlining the data collection process. Our expert support team stands ready to assist at every step, ensuring the highest standards of data accuracy and security throughout your clinical trials. Trust oomnia for precision in data management and efficient trial execution.

More about oomnia EDC/eCRF here

eSource

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Connecting all digital data sources
oomnia has powerful eSource capabilities, which enable you to connect all other digital data sources to omnia EDC. Our software is able to capture all kinds of electronic source data in real time, such as electronic health records (EHRs), wearable technologies or mobile applications. In this way, we are ensuring highest data accuracy and enhanced clinical workflows.

More about oomnia eSource here

RTSM

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Enhancing trial efficiency
Within oomnia, our Randomization and Trial Supply Management (RTSM) module offers complete lifecycle coverage for kit shipment tracking and real-time status updates. From randomization, and allocation to treatment, as well as accountability, and end-of-trial randomization report exports, the RTSM as part of a unified system reduces manual data entry and streamlines the entire trial process by increasing transparency and eliminating needless manual reconciliation. By optimizing supply chain management and data accuracy, oomnia's RTSM tool ensures efficient and error-free clinical trials, saving time and resources for research teams.

More about oomnia RTSM here

eTMF

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Streamlined document management
oomnia incorporates electronic Trial Master File (eTMF) capabilities to optimize your document management process. Benefit from real-time reports, a rapid startup timeline, and effortless document management. Our eTMF tool ensures insights into your trial's progress, and it is exportable to a fully validated eArchive for long-term data storage. Count on oomnia for comprehensive document control and efficient trial management, empowering you with convenience and confidence throughout your trials.

More abut oomnia eTMF here

ePRO

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Revolutionizing data reporting
Within oomnia, electronic Patient-Reported Outcomes (ePRO) emerges as a vital tool. Patients can seamlessly report their health data through smartphones, tablets, or web-based platforms, enhancing their active engagement in the healthcare process. This integration not only boosts patient involvement but also elevates data quality, delivering a more precise understanding of a patient's health. With ePRO as part of oomnia you benefit from improved communication and streamlined data collection, ultimately enhancing the quality of care.

More about oomnia ePRO here

eCOA

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Elevating clinical assessments
oomnia seamlessly incorporates electronic Clinical Outcome Assessments (eCOA) for comprehensive data collection and documentation. Utilizing electronic devices such as smartphones, tablets, or web-based platforms, eCOA enhances data integrity and efficiency in clinical assessments. This integration simplifies the process, ensuring accurate and timely collection of vital clinical data, ultimately advancing patient outcomes.

More about oomnia eCOA here

eConsent

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Simplifying consent processes
oomnia eConsent enables patients to choose the most convenient consent process. Our solution supports electronic as well as paper-based consent methods. It further comes with numerous features. Our tool reduces language barriers by providing consent documents in multiple languages. In addition, the interactive Q&A module allows participants to directly communicate with site staff, which gives them opportunities to raise concerns or questions. The digital signing process reduces the time needed to disseminate consent information to just three minutes.

More about oomnia eConsent here

CTMS

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Elevating trial management
oomnia integrates Clinical Trial Management System (CTMS) features to enhance your trial management experience. Our platform offers customized dashboards per user role, standard study templates, and logs for efficient trial setup. With key performance indicator (KPI) reports, monitoring visit tracking, and timeline/milestone tracking, you gain full visibility into your trial's progress. Additionally, our CTMS tool covers contract management and budget/payment management, ensuring comprehensive trial oversight. Trust oomnia for streamlined and data-driven trial management that empowers you to achieve your research goals effectively.

More about oomnia CTMS here

Professional Trial Services

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Empowering your clinical trials with professional services

To complement our clinical trial software tools, we offer a comprehensive suite of professional trial services. From planning to closure, we're your trusted partner every step of the trial workflow.

Some of our services include:

Trial Planning:

Trial Conduct:

Trial Closure:

Our dedicated team of professional experts ensures your trials are conducted efficiently, with data integrity and regulatory compliance at the forefront.

More about our professional services here

Highest data security

You decide where to store your data and who and how to access it. We fulfill all regulatory standards for secure data storage and exchange.

True
collaboration

Collaborate within oomnia to optimally support your workflow in real time and with audit logs.

Insightful analytics and assets

Experience the next level of comprehensive knowledge database and real-time metrics to generate new insights and assets.

Convenient customization

Flexibility is our commitment. oomnia adapts to your needs and workflow. Create your own documents, utilize templates, and save time.

Professional services

Elevate your trial management experience with our dedicated team

Our professional trial services complement your expertise. We support you with optimal trial implementation, management, and finalization.
We are offering clinical advisory, protocol development, data management, medical writing, biostatistics, and more. We are ready to work hand in hand with your team, as needed.

Let us enhance clinical excellence together.

MAKE AN IMPACT WITH OOMNIA

Ease your processes and unlock your potential

Work with oomnia and experience efficiency and precision like never before.

User-friendly interface

Boost efficiency and user satisfaction

Unlock the power of simplicity with our intuitive user-friendly interface. Navigate complex tasks effortlessly, with no technical expertise required. Experience efficiency and ease.

Infinite trial types

oomnia adapts to your evolving needs so your research never has to compromise

Navigate the complexity of any trial-hybrid, decentralized, synthetic, real-world data, or medical device bringing together fragmented processes for comprehensive management. oomnia recognizes and adapts to the distinct requirements of each trial type, ensuring seamless management, impeccable data integrity, compliance, and security. Transform your research with a software that molds to fit your needs, not the other way around.

Data security

Experience highest data protection with oomnia’s advanced security features

In today’s digital age, data security is a fundamental aspect of any software solution, particularly in the field of clinical trials. Recognizing this imperative, our platform is built with the most robust security protocols, ensuring that every piece of data is encrypted, securely stored, and protected against unauthorized access. Our commitment to data security means you can trust us with your most sensitive information, knowing it is safeguarded with the utmost care and professionalism.

Get the maximum out of your trials

Unlock future success with infinite possibilities of oomnia

Discover the impact of oomnia on your research outcomes and budget. But it is not just about the savings; it’s about what you can achieve with us.
 
Let us together reshape the clinical research landscape, proving that true value lies in making a significant and lasting difference in your projects and the wider world.
 
Discover the true value of oomnia.

SETTING THE BAR FOR QUALITY STANDARDS IN THE INDUSTRY

Swiss excellence in every detail

Our secret? A mix of real-world medical know-how and top-notch tech skills, all from the heart of Switzerland.

Powerful software for clinical research and practice

Revolutionizing clinical outcomes with cutting-edge technology and expertise

“We bring the highest quality clinical data to the world of clinical research and practice, accelerating medical progress and saving lives.“

Nikola Cihoric, M.D.
Clinical Informatics Architect and Founder of Wemedoo

SWITCH TO OOMNIA NOW.

Join us on our journey to advance clinical research together.