Precise and fast data capturing with oomnia EDC & eCRF
Streamline your Data Collection, Ensuring Analysis-Ready Datasets the Moment they are Entered
- NData integration capabilities
- NConvenient user interface
- NReal-time data validation
- NCustomizable dashboards
Precise and fast data capturing with oomnia EDC & eCRF
Streamline your Data Collection, Ensuring Analysis-Ready Datasets the Moment they are Entered
- NData integration capabilities
- NConvenient user interface
- NReal-time data validation
- NCustomizable dashboards
Discover the capabilities of oomnia EDC firsthand
Electronic data capture and eCRFs are an integral part of our unified clinical research software oomnia. It is part of our unique, fully digitized solution for collecting, cleaning, and reviewing data throughout the clinical trial life cycle.
Experience the power of oomnia EDC
Transform your data management
Revolutionizing clinical data collection with oomnia eCRF
Enhance data precision
Our eCRFs created within oomnia streamline the data collection process and save resources. They are directly integrated with the RTSM, laboratory management, SAE report forms, protocol deviation logs, and more. Furthermore, direct access to the CDISC metadata standards browser saves your time and ensures regulatory compliance. Trust oomnia for precision in data management and efficient trial execution.
Benefits of our unified EDC
Harness the full potential of clinical data
Advanced features of oomnia EDC
Unlock the full potential of your clinical trials
Accurate data capture
Experience precision like never before
Integration with the CDISC metadata standards browser enables easy compliance with data capture and metadata standards. Search the CDASH metadata and controlled terminology directly from within the EDC field designer.
Customizable data capture forms
- Flexible drag-and-drop form design tools for the creation of data capture forms tailored to the specific needs of your clinical trial
- Option to link any fields, forms, or visits to each other for dynamic behaviour or data validation and discrepancy checks
Integrated systems
Automated SAE report form generation
- oomnia EDC streamlines the capture, reporting, and analysis of Serious Adverse Events (SAEs)
- Auto-generation of SAE report forms from the eCRF enables to capture initial, follow-up, and final SAE reports directly within EDC
- Automation drastically saves time and money by reducing reconciliation between a participant eCRF and the SAE report form
Adaptive data collection
- Quickly and easily modify data collection forms during trial conduct, without compromising timelines or data integrity
- Change data validation and discrepancy checks on the fly within minutes
Unlimited data export and reporting
- Data analytics with real-time integrated graphical reports help generate meaningful insights
- Custom integrated graphical reports enable tracking in any manner necessary
- Creation of custom templated data dumps allows to export specific data sets at the click of a button
Electronic Protocol Deviation Log (ePDL)
- Get custom electronic Protocol Deviation Log (ePDL) form directly inside the EDC system
- Automatically associate protocol deviations with a site, or participant
- Recreate SOP processes directly in the ePDL, and evaluate whether a deviation may affect trial outcomes, data integrity, or participant safety
- Identify trends that can lead to changes in the protocol or training improvements to prevent similar deviations in the future
Customizable data capture forms
- Flexible drag-and-drop form design tools for the creation of data capture forms tailored to the specific needs of your clinical trial
- Option to link any fields, forms, or visits to each other for dynamic behaviour or data validation and discrepancy checks
Integrated systems
Automated SAE report form generation
- oomnia EDC streamlines the capture, reporting, and analysis of Serious Adverse Events (SAEs)
- Auto-generation of SAE report forms from the eCRF enables to capture initial, follow-up, and final SAE reports directly within EDC
- Automation drastically saves time and money by reducing reconciliation between a participant eCRF and the SAE report form
Adaptive data collection
- Quickly and easily modify data collection forms during trial conduct, without compromising timelines or data integrity
- Change data validation and discrepancy checks on the fly within minutes
Unlimited data export and reporting
- Data analytics with real-time integrated graphical reports help generate meaningful insights
- Custom integrated graphical reports enable tracking in any manner necessary
- Creation of custom templated data dumps allows to export specific data sets at the click of a button
Electronic Protocol Deviation Log (ePDL)
- Get custom electronic Protocol Deviation Log (ePDL) form directly inside the EDC system
- Automatically associate protocol deviations with a site, or participant
- Recreate SOP processes directly in the ePDL, and evaluate whether a deviation may affect trial outcomes, data integrity, or participant safety
- Identify trends that can lead to changes in the protocol or training improvements to prevent similar deviations in the future
Data validation and audit trails
Ensure impeccable data quality
Real-time data validation
- oomnia EDC includes advanced real-time data validation checks, within and between eCRF pages, and/or participant visits or forms
- oomnia EDC enables quickly and easily set up of any type of univariate or multivatiate edit check, even while the study is in progress
Source Data Verification (SDV)
- Easily perform and track SDV progress, ensuring accuracy, completeness, and compliance, while prioritizing critical data and audit readiness
- Define data for mandatory SDV
- Create SDV rules for signatures, document lock, or even if SDV is required on data capture fields
- Track SDV progress in real-time via integrated graphical reports
Automatic data cleaning
- Easily implemented dynamic behaviour allows to display only fields based on data entered into previous fields, forms, and/or participant visits
- Data cleaning is automatically performed by oomnia system resulting up to 67% fewer queries than industry standard software
Audit trails
- Our audit trails are easily accessible for all EDC documents and can be filtered by data entry, SDV, query status, and more
- The audit trails can be exported by data managers in various file formats, which are easily understood for study team members, but also suitable for computed analytics
- Custom integrated graphical reports are available for audit trail review
Real-time data validation
- oomnia EDC includes advanced real-time data validation checks, within and between eCRF pages, and/or participant visits or forms
- oomnia EDC enables quickly and easily set up of any type of univariate or multivatiate edit check, even while the study is in progress
Source Data Verification (SDV)
- Easily perform and track SDV progress, ensuring accuracy, completeness, and compliance, while prioritizing critical data and audit readiness
- Define data for mandatory SDV
- Create SDV rules for signatures, document lock, or even if SDV is required on data capture fields
- Track SDV progress in real-time via integrated graphical reports
Automatic data cleaning
- Easily implemented dynamic behaviour allows to display only fields based on data entered into previous fields, forms, and/or participant visits
- Data cleaning is automatically performed by oomnia system resulting up to 67% fewer queries than industry standard software
Audit trails
- Our audit trails are easily accessible for all EDC documents and can be filtered by data entry, SDV, query status, and more
- The audit trails can be exported by data managers in various file formats, which are easily understood for study team members, but also suitable for computed analytics
- Custom integrated graphical reports are available for audit trail review
Why oomnia
Integrated 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
Intuitive user-interface
Enhance user experience
oomnia EDC system has a user-interface that allows easy data entry and navigation. This helps to reduce the time spent on data entry and results in increased efficiency.
Intuitive navigation
- Intuitive interface with easy-to-navigate menus and options, reducing training time
- Quickly access to the information you need without confusion
- Simultaneous and independent work in multiple tabs
- Understandable user feedback
- The same interface for all roles, reducing training time, simplifying navigation as well as troubleshooting
- A significant reduction in the number of support calls
User role allocation
- User roles are defined for each study and each module, with granular permissions for any EDC document type
- Settings can be saved and reused in the future
User-centered design
- Intuitive user-centric design minimizes requirements for training and support requests, facilitates faster data entry and data cleaning, and reduces overall time spent on data capture efforts
- Our team designed interface with the end user in mind, with particular attention to efficiency, effectiveness, error tolerance, and ease of learning
- As a result, users get a more manageable data capture process, with fewer queries and redundancies
Data security and protection
Safeguard your trial information
oomnia EDC system ensures the security of patient data through state of the art encryption and security. This also ensures compliance with data protection regulations such as HIPAA in the US or GDPR in Europe.
Access controls
- Implementing strict role-based access controls that limit data access to authorized personnel only
- Two-factor authentication for logins and signatures on a role-by-role basis
Regular security assessments and updates
- Conducting periodic security assessments and ensuring that the system's security measures are updated regularly to protect against new vulnerabilities and threats
Encryption
- Data in transit and at rest is encrypted using advanced encryption standards
- Encrypting data is included within the system and any data being transmitted between systems or to external entities
Data backup and recovery
- Regularly scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, especially in the event of system failures or other unforeseen incidents
Access controls
- Implementing strict role-based access controls that limit data access to authorized personnel only
- Implement two-factor authentication for logins and signatures on a role-by-role basis
Regular security assessments and updates
- Conducting periodic security assessments and ensuring that the system's security measures are updated regularly to protect against new vulnerabilities and threats
Encryption
- Data in transit and at rest is encrypted using advanced encryption standards
- Encrypting data is included within the system and any data being transmitted between systems or to external entities
Data backup and recovery
- Regularly scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, especially in the event of system failures or other unforeseen incidents
oomnia – Surpassing Industry Standards
Our unified clinical trial software is designed with compliance at its core, meeting critical industry standards. Our commitment to these regulations ensures that your clinical trials are not only efficient but also adhere to the highest levels of data integrity, privacy, and ethical conduct.
Real-time data access and monitoring
Unlock fast insights and oversight
Trial staff can access and monitor the collected data in real time. This enables continuous monitoring of study progress and faster issue resolution. Real-time data dumps or exports and reports can be generated at will.
Real-time data visualization
- View and analyze data as soon as it is entered into the system
- Profit from dashboards and graphical representations of trial progress, participant enrollment, and other key metrics
Remote monitoring capabilities
- The tools enable remote monitoring of trial sites, facilitating oversight without the need for physical site visits
- This is particularly useful for multicenter or global trials
Live data reporting
- Continuous tracking of data entries and changes, allowing trial managers and stakeholders to monitor the latest developments in the trial as they occur
Real-time data visualization
- View and analyze data as soon as it is entered into the system
- Profit from dashboards and graphical representations of trial progress, participant enrolment, and other key metrics
Remote monitoring capabilities
- The tools enable remote monitoring of trial sites, facilitating oversight without the need for physical site visits
- This is particularly useful for multicenter or global trials
Live data reporting
- Continuous tracking of data entries and changes, allowing trial managers and stakeholders to monitor the latest developments in the trial as they occur
Data evaluation and reporting
Elevate your data insights
Integrated graphical reports
- Visual representation of data through charts, graphs, and infographics, which is important for easy interpretation and communication of complex data sets to various stakeholders
- Statistical analysis of data for study conduct analyses, as well as comparisons across sites, or other metrics as needed
- oomnia system unification for simultaneously information pull from all functionalities, simplifying tracking and trial management
Automated data validation reports
- Automated checks and validation reports for data accuracy and consistency, which is critical for maintaining the integrity of the trial data
- Tracking of error rates by participant, site, country, or eCRF, ePDL, or SAE Report Form
- Reporting of data discrepancies using any metric available
Customizable reporting
- Standard template reports can easily be customized to meet stakeholder needs per study
- New reports can also be created to incorporate additional data or to present the data in different outlays to facilitate study oversight, monitoring, and reporting
- Dashboards are created to be user-specific, providing the most critical study status updates upon sign-on
Data export options
- Use flexible data export options, enabling data to be exported in various formats (e.g., CSV, PDF, Excel) for further analysis or sharing with stakeholders
- Create templated data exports according to stakeholder request
- Choose any combination of data capture fields to create the template, and export per participant, site, country, or any combination thereof
Integrated graphical reports
- Visual representation of data through charts, graphs, and infographics, which is important for easy interpretation and communication of complex data sets to various stakeholders
- Statistical analysis of data for study conduct analyses, as well as comparisons across sites, or other metrics as needed
- oomnia system unification for simultaneously information pull from all functionalities, simplifying tracking and trial management
Automated data validation reports
- Automated checks and validation reports for data accuracy and consistency, which is critical for maintaining the integrity of the trial data
- Tracking of error rates by participant, site, country, or eCRF, ePDL, or SAE Report Form
- Reporting of data discrepancies using any metric available
Customizable reporting
- Standard template reports can easily be customized to meet stakeholder needs per study
- New reports can also be created to incorporate additional data or to present the data in different outlays to facilitate study oversight, monitoring, and reporting
- Dashboards are created to be user-specific, providing the most critical study status updates upon sign-on
Data export options
- Use flexible data export options, enabling data to be exported in various formats (e.g., CSV, PDF, Excel) for further analysis or sharing with stakeholders
- Create templated data exports according to stakeholder request
- Choose any combination of data capture fields to create the template, and export per participant, site, country, or any combination thereof
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Complementary services
Unlock more possibilities
Protocol development
Delve into how our expertly crafted protocols provide a solid foundation for your research, ensuring rigorous design, clear objectives, and compliance with regulatory standards. Our service emphasizes a collaborative approach. Therefore, it tailors protocols to meet the unique needs of each study while maintaining the highest standards of scientific integrity and operational efficiency. Get more information about our Protocol Development service.
Clinical data management
Our service is designed to ensure the highest standard of data accuracy, compliance, and management throughout your trial's lifecycle. We always exceed industry expectations, by applying our unique way of thinking and approach, with our cutting-edge technology and industry expertise. Dive into our Clinical Data Management service.
Risk-based monitoring and 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 and statistical programming
Before the study’s commencement, biostatistical methods are used to oversee the study design in terms of calculating the sample size, and providing randomization solutions to compose a scientifically sound performance. As the data collection is complete and clinical study brought to a close, biostatistics provide a quantitative framework for interpreting the study results. Learn more about our Biostatistics and Statistical Programming service.
CDISC-compliant dataset generation
Wemedoo covers all steps and deliverables. Our meticulous approach transforms collected data into a thorough and complete clinical study data submission package, ready for regulatory authorities. This includes SDTM/SEND and ADaM datasets, Define.XML files and associated reviewers guides and documentation. Learn how to simplify your path to regulatory compliance and submission with our CDISC-Compliant Dataset Generation service.
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."
"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."
Access a comprehensive EDC data sheet
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Frequently asked questions
Get the answers you need about oomnia EDC
What is the oomnia EDC System?
The oomnia EDC system is designed to simplify and streamline complex clinical trial processes. It offers an intuitive user interface with easy-to-navigate menus and customizable dashboards, allowing researchers to effectively focus on essential data. The oomnia EDC is an integral part of the unified oomnia clinical trial software, seamlessly communicating with the RTSM, laboratory management, CTMS, ePRO, and eCOA. This makes it the most powerful, time, and cost saving clinical research tool on the market.
How does oomnia EDC handle real-time data capture?
Data integrity is a top priority in clinical trials. oomnia EDC ensures real-time data capture, providing immediate and accurate recording of all trial data. This enhances data reliability, and supports swift decision-making by enabling real time reporting and visual analytics.
Is oomnia EDC compliant with regulatory standards?
What are the steps in implementing oomnia EDC?
Setup: oomnia assists in creating the trial structure, implementing electronic Case Report Forms (eCRFs), and establishing randomization schedules.
Access: The system ensures secure, role-specific access, incorporating advanced security measures like two-factor authentication.
Enroll: Streamlines participant enrollment and management, integrating seamlessly with Randomization and Trial Supply Management (RTSM) systems.
How does data collection process work using eCRF within oomnia EDC?
eCRFs are designed to capture all the necessary data for the clinical trial. These forms are created within the EDC system and are tailored to the specific requirements of the trial protocol. They include various fields to collect patient data, including medical history, treatment responses, lab results, and adverse events. During the trial, data is entered into the eCRFs directly by the clinical trial staff at each participant visit. This can be done at the site where the trial is being conducted, often in real-time as the patient is being assessed. In some cases, ePRO (electronic Patient Reported Outcomes) tools allow patients themselves to enter data directly into the system.
What types of trial data can I collect using oomnia?
In oomnia EDC forms can be created to collect any clinical trial data. Of course eCRFs, but we go way beyond, create ePDLs, auto generating SAE report forms, immunogenicity forms, any types of logs, and much more. It simplifies query management, source data verification, and study data review.
What monitoring features does oomnia offer?
oomnia provides comprehensive monitoring features, including real-time statistical analysis, risk-based monitoring, and visualization of site performance.
How can I book a demo and experience oomnia for myself?
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