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

Electronic data capture (EDC) and electronic Case Report Forms (eCRFs) are integral to oomnia, our unified clinical research software. These features are part of our fully digitized solution for collecting, cleaning, and reviewing data throughout the clinical trial lifecycle.

Experience the power of oomnia EDC

Transform your data management processes

With data integration capabilities, customized dashboards, and real-time reports, you can confidently oversee and manage clinical trials with ease. Paired with other oomnia features, our EDC provides a flexible, role-specific, and accessible platform. Moreover, you will find role-specific dashboards to streamline clinical trial data and operational oversight. Within oomnia, our Electronic Data Capture (EDC) tool offers extensive capabilities to design a wide range of EDC forms, such as eCRF, SAE report forms, protocol deviation logs, and other critical documentation. Equipped with user-friendly configuration, controlled user access, and robust data integration, our system is a leading solution in the industry.
Illustration shows all oomnia clinical trial software tools.

Revolutionizing clinical data collection with oomnia eCRF

Enhance data precision

Our eCRFs, designed within oomnia, streamline data collection process and maximize resource efficiency. Directly integrated with RTSM, laboratory management, SAE report forms, protocol deviation logs, and more, they provide seamless functionality for a cohesive clinical trial workflow. Furthermore, direct access to the CDISC metadata standards browser saves time and ensures compliance with regulatory requirements. You can rely on oomnia for precision in data management and efficient trial execution.

Benefits of our unified EDC

Harness the full potential of clinical data

Unlock the exceptional advantages of oomnia EDC software, designed to propel your clinical trials to new heights of efficiency and success. Whether you are a principal investigator, clinical data manager, trial director, biostatistician, study coordinator or clinical research associate, you can benefit from the powerful potential of oomnia EDC. Delve into the profits of remarkable time and cost savings, coupled with a dedication to delivering top-tier results for your clinical research projects.

Advanced features of oomnia EDC

Unlock the full potential of your clinical trials

oomnia EDC solution presents a curated set of features designed to meet the requirements of the most demanding industry professionals. Explore capabilities that streamline data collection, enhance compliance, save time and resources, and elevate the quality of clinical research.

Accurate data capture

Experience precision like never before

oomnia EDC enables the electronic capture of patient data directly at the point of data collection (e.g. in clinics or trial centers). This includes clinical data, laboratory data, participant surveys, and all other relevant information.

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

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  • 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

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  • oomnia EDC integrates data from various sources, including electronic health records, medical devices (including wearables), and central and local laboratories
  • It is inherently unified with our ePRO, RTSM, reporting, eTMF, laboratory management, and CTMS

Automated SAE report form generation

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  • 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

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  • 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

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  • 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)

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  • 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

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  • 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

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  • oomnia EDC integrates data from various sources, including electronic health records, medical devices (including wearables), and central and local laboratories
  • It is inherently unified with our ePRO, RTSM, reporting, eTMF, laboratory management, and CTMS

Automated SAE report form generation

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  • 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

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  • 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

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  • 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)

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  • 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

oomnia EDC system provides real-time validation capabilities to ensure that the data entered is accurate and complete. It can generate automatic alerts and error messages when inconsistent or missing data is detected.

Real-time data validation

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  • 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)

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  • 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

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  • 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

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  • 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

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  • 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)

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  • 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

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  • 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

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  • 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

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

Intuitive user-interface

Enhance user experience

oomnia EDC system has a user interface that allows easy data entry and navigation. This helps reduce the time spent on data entry and increases efficiency.

Intuitive navigation

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  • 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

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  • 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

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  • 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

The oomnia EDC system ensures the security of patient data through state-of-the-art encryption and security. It also ensures compliance with data protection regulations such as HIPAA in the US and GDPR in Europe.

Access controls

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  • 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

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  • We conduct periodic security assessments and ensure that the system's security measures are updated regularly to protect against new vulnerabilities and threats

Encryption

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  • 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

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  • Scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, even during system failures or unforeseen incidents

Access controls

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  • 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

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  • We conduct periodic security assessments and ensure that the system's security measures are updated regularly to protect against new vulnerabilities and threats

Encryption

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  • 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

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  • Scheduled backups and reliable data recovery systems prevent data loss and ensure data integrity, even during system failures or unforeseen incidents

FDA Inspection Passed Without Any Findings
Wemedoo ensures its validation procedures meet and surpass industry and regulatory standards. This underscores our commitment to software compliance, secure operations, and high-quality software.

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, exports, and reports can be generated at will.

Real-time data visualization

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  • 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

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  • 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

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  • 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

Seamless data flow and synchronization

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  • As oomnia is one unified system, data flows smoothly between the EDC, CTMS, eTMF, and RTSM systems
  • This unified system provides a single database with all clinical research information at your fingertips

Real-time data visualization

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  • 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

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  • 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

Seamless data flow and synchronization

:
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  • As oomnia is one unified system, data flows smoothly between the EDC, CTMS, eTMF, and RTSM systems
  • This unified system provides a single database with all clinical research information at your fingertips

Data evaluation and reporting

Elevate your data insights

oomnia EDC facilitates data evaluation and analysis by providing tools to generate reports and graphs useful for assessing study results.

Integrated graphical reports

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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.

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 with optimal trial implementation, management, and finalization. For EDC, our services include, for example, protocol development, clinical data management, and more. We are ready to work hand in hand with your team as needed.

Protocol development

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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 that 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

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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

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Our service is dedicated to ensuring the highest quality, accuracy, validity, and reliability of your clinical trial data. It 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 begins, biostatistical methods guide study design, including sample size calculation and randomization solutions, to ensure scientific rigor. Once data collection is complete and the clinical study concludes, biostatistics provide a quantitative framework for interpreting the study results. Learn more about our Biostatistics and Statistical Programming service.

CDISC-compliant dataset generation

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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, associated reviewers' guides, and documentation. Learn how to simplify your path to regulatory compliance and submission with our CDISC-Compliant Dataset Generation 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 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?

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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 focus effectively on essential data. The oomnia EDC is an integral part of the unified clinical trial software, seamlessly communicating with the RTSM, laboratory management system (LMS), 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?

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Data integrity is a top priority in clinical trials. oomnia EDC ensures real-time data capture, providing immediate and accurate data recording. This enhances data reliability and supports swift decision-making by enabling real-time reporting and visual analytics.

Is oomnia EDC compliant with regulatory standards?

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Yes, the oomnia EDC system aligns with rigorous standards set by regulatory authorities, including FDA 21 CFR Part 11 and EMA's EU GMP Annex 11 guidelines.

What are the steps in implementing oomnia EDC?

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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?

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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, laboratory results, and adverse events. During the trial, data are 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?

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In oomnia, EDC forms can be created to collect any clinical trial data. Of course, eCRFs, but we go way beyond: creating ePDLs, auto-generating SAE report forms, immunogenicity forms, various types of logs, and much more. It simplifies query management, source data verification, and study data review.

What monitoring features does oomnia offer?

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oomnia offers comprehensive monitoring features, including real-time statistical insights, advanced risk-based monitoring, and interactive visualization of site performance metrics.

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

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To book a demo with an oomnia expert, simply click the button below, select a date in the booking tool, and provide the required information. After that, we will send you an invitation.

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Uncover the synergy of solutions tailored to your success

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.