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
Experience the power of oomnia EDC
Transform your data management processes
Revolutionizing clinical data collection with oomnia eCRF
Enhance data precision
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 behavior 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 significantly reduces reconciliation time and costs 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 exporting specific data sets at the click of a button
Electronic Protocol Deviation Log (ePDL)
- Get custom electronic Protocol Deviation Log (ePDL) forms 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 behavior 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 significantly reduces reconciliation time and costs 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 exporting specific data sets at the click of a button
Electronic Protocol Deviation Log (ePDL)
- Get custom electronic Protocol Deviation Log (ePDL) forms 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 validation checks across eCRF pages, participant visits, and forms
- It enables users to quickly and easily set up any type of univariate or multivariate edit check, even during an ongoing study
Source Data Verification (SDV)
- Easily perform and track SDV progress, ensuring accuracy, completeness, and compliance while prioritizing critical data and audit readiness
- Define mandatory SDV requirements
- Create SDV rules for signatures, document locking, or specifying SDV requirements for data capture fields
- Track SDV progress in real time via integrated graphical reports
Automatic data cleaning
- Easily implemented dynamic behavior allows the system to display only the fields based on data entered into previous fields, forms, and participant visits
- Data cleaning is automatically performed by the oomnia system, resulting in up to 67% fewer queries compared to industry-standard software
Audit trails
- Our audit trails are easily accessible for all documents within the EDC system 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 easy for study team members to understand and suitable for computational analytics
- Custom graphical reports are available for audit trail review
Real-time data validation
- oomnia EDC includes advanced real-time validation checks across eCRF pages, participant visits, and forms
- It enables users to quickly and easily set up any type of univariate or multivariate edit check, even during an ongoing study
Source Data Verification (SDV)
- Easily perform and track SDV progress, ensuring accuracy, completeness, and compliance while prioritizing critical data and audit readiness
- Define mandatory SDV requirements
- Create SDV rules for signatures, document locking, or specifying SDV requirements for data capture fields
- Track SDV progress in real time via integrated graphical reports
Automatic data cleaning
- Easily implemented dynamic behavior allows the system to display only the fields based on data entered into previous fields, forms, and participant visits
- Data cleaning is automatically performed by the oomnia system, resulting in up to 67% fewer queries compared to industry-standard software
Audit trails
- Our audit trails are easily accessible for all documents within the EDC system 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 easy for study team members to understand and suitable for computational analytics
- Custom 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
- Enhanced usability
- Easy learning curve
- Adaptive flexibility
- Exceptional services
- Instant collaboration
- Swift validation process
Intuitive user-interface
Enhance user experience
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, and 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 that can be applied to any EDC document type
- Settings can be saved and reused later
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 data queries and redundancies
Data security and protection
Safeguard your trial information
Access controls
- We implement strict role-based access controls that limit data access to authorized personnel only
- We use two-factor authentication for logins and signatures on a role-by-role basis
Regular security assessments and updates
- We conduct periodic security assessments and ensure 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
- The system ensures that all data being transmitted between systems or to external entities is encrypted
Data backup and recovery
- Scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, even during system failures or unforeseen incidents
Access controls
- We implement strict role-based access controls that limit data access to authorized personnel only
- We use two-factor authentication for logins and signatures on a role-by-role basis
Regular security assessments and updates
- We conduct periodic security assessments and ensure 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
- The system ensures that all data being transmitted between systems or to external entities is encrypted
Data backup and recovery
- Scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, even during system failures or unforeseen incidents
Real-time data access and monitoring
Unlock fast insights and oversight
Real-time data visualization
- View and analyze data as soon as it is entered into the system
- Benefit 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, enabling oversight without physical site visits
- This is particularly useful for multicenter or global trial
Live data reporting
- Tracking of data entries and changes in real time allows 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
- Benefit 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, enabling oversight without physical site visits
- This is particularly useful for multicenter or global trial
Live data reporting
- Tracking of data entries and changes in real time allows 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 facilitates easy interpretation and communication of complex data to stakeholders
- Statistical analysis of data supports study conduct and comparisons across sites or other relevant metrics
- oomnia system unification enables simultaneous information retrieval from all functionalities, simplifying tracking and trial management
Automated data validation reports
- Automated checks and validation reports ensure data accuracy and consistency, maintaining trial data integrity
- Error rates can be tracked by participant, site, country, or across forms such as eCRFs, ePDLs, or SAE Report Forms
- Data discrepancies can be reported using customizable metrics
Customizable reporting
- Standard template reports can be easily customized to meet study-specific stakeholder needs
- New reports can also be created to incorporate additional data or present it in different layouts, facilitating study oversight, monitoring, and reporting
- User-specific dashboards provide critical study status updates upon sign-on
Data export options
- Flexible export options enable data to be shared in various formats (e.g., CSV, PDF, Excel) for analysis or stakeholder communication
- Create templated data exports based on stakeholder requests
- Choose any combination of data capture fields to create the template, and export data by participant, site, country, or any combination thereof
Integrated graphical reports
- Visual representation of data through charts, graphs, and infographics facilitates easy interpretation and communication of complex data to stakeholders
- Statistical analysis of data supports study conduct and comparisons across sites or other relevant metrics
- oomnia system unification enables simultaneous information retrieval from all functionalities, simplifying tracking and trial management
Automated data validation reports
- Automated checks and validation reports ensure data accuracy and consistency, maintaining trial data integrity
- Error rates can be tracked by participant, site, country, or across forms such as eCRFs, ePDLs, or SAE Report Forms
- Data discrepancies can be reported using customizable metrics
Customizable reporting
- Standard template reports can be easily customized to meet study-specific stakeholder needs
- New reports can also be created to incorporate additional data or present it in different layouts, facilitating study oversight, monitoring, and reporting
- User-specific dashboards provide critical study status updates upon sign-on
Data export options
- Flexible export options enable data to be shared in various formats (e.g., CSV, PDF, Excel) for analysis or stakeholder communication
- Create templated data exports based on stakeholder requests
- Choose any combination of data capture fields to create the template, and export data by participant, site, country, or any combination thereof
SWITCH TO OOMNIA NOW.
Complementary services
Unlock more possibilities
Protocol development
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
Biostatistics and statistical programming
CDISC-compliant dataset generation
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."
"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."
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Frequently asked questions
Get the answers you need about oomnia EDC
What is the oomnia EDC System?
How does oomnia EDC handle real-time data capture?
Is oomnia EDC compliant with regulatory standards?
What are the steps in implementing oomnia EDC?
Set up: 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 such as two-factor authentication.
Enroll: Facilitates participant enrollment and management, integrating seamlessly with RTSM systems for seamless integration.
How does data collection process work using eCRF within oomnia EDC?
What types of trial data can I collect using oomnia?
What monitoring features does oomnia offer?
How can I book a demo and experience oomnia for myself?
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