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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

Data integration capabilities, customized dashboards, and real-time reports enable you to oversee and manage your clinical trial effectively and efficiently. Paired with other oomnia features, our EDC provides you with a flexible, versatile, integrated, role-specific and accessible platform. Moreover, you will find customized dashboards per role to facilitate clinical trial data and operational oversight. Within oomnia, our Electronic Data Capture (EDC) tool offers comprehensive capabilities to create any type of EDC form, including eCRF, SAE report form, protocol deviation logs, and many more. Equipped with user-friendly configuration, controlled user access, as well as data integration and processing, our system is the best in the business.

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.

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EDC features
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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, biostatitian, 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.

Protocol Deviation

Centralized Protocol Deviation Log and easy generation of deviation enable streamlined tracking of protocol deviations and manage protocol non-compliance. And our data-driven insights ensure potential improvements in protocol adherence.

Data Quality

Our EDC system’s design focuses on minimizing data entry errors. Real-time validation checks during data entry to ensure accuracy. Audit trails and data tracking ensure your data integrity and compliance.

Data Collection

Our automated EDC forms save your time and money by minimizing error-prone manual data entry, reducing reconciliation. Efficient data capture processes lead to quicker and more accurate data analysis. And our customizable reporting tools ensure data interpretation and dissemination.

Error Reduction

We offer a well-designed eCRF that significantly lowers data entry errors. Up to 67% decrease in manual queries due to reduced data entry errors. Our automated forms minimize reconciliation needs and manual entries.

Time Savings

You can setup, deploy, and validate eCRFs in weeks instead of months. Our proper initial setup reduces future problems and avoids later interventions. And easy to set up data validation as well as data discrepancy checks dramatically reduce DB Lock time.

Cost Savings

Our unified EDC allows to save up to 67% of time spent by CRAs on query resolution. Minimize rounds of EDC form development using efficient pre-validated design processes requiring no programming. Immediate access to real time reports enable faster issue detection and resolution.

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 of industry professionals. Dive into capabilities that save time and resources, streamline data collection, enhance compliance, and elevate the quality of your 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 behaviour or data validation and discrepancy checks

Integrated systems

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  • oomnia EDC is capable of integrating data from various sources, including electronic health records, medical devices (including wearables), 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 drastically saves time and money by reducing reconciliation 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 to export 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) 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

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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 behaviour or data validation and discrepancy checks

Integrated systems

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  • oomnia EDC is capable of integrating data from various sources, including electronic health records, medical devices (including wearables), 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 drastically saves time and money by reducing reconciliation 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 to export 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) 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

oomnia EDC systems provide real-time validation capabilities to ensure that the data entered is accurate and complete. They 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 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)

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  • 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

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  • 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

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  • 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

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  • 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)

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  • 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

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  • 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

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  • 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, RTSM, ePRO, eCOA, eSource, CTMS, and eTMF

All of the tools oomnia provides are part of a unified system and support multiple trials on a single instance. Learn more about the full potential of oomnia.
  • Unified SaaS-solution
  • Real-time analytics
  • Full interoperability
  • Unmatched user experience
  • Easy learning curve
  • Adaptive flexibility
  • Exceptional services
  • Instant collaboration
  • Swift validation process
Get more information

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

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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 as well as 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 for any EDC document type
  • Settings can be saved and reused in the future

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 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

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  • 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

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  • Conducting periodic security assessments and ensuring 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
  • Encrypting data is included within the system and any data being transmitted between systems or to external entities

Data backup and recovery

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  • 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

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  • 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

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  • Conducting periodic security assessments and ensuring 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
  • Encrypting data is included within the system and any data being transmitted between systems or to external entities

Data backup and recovery

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  • 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

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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

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  • 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

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  • 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

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  • Continuous tracking of data entries and changes, allowing 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
  • It represents 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
  • Profit from dashboards and graphical representations of trial progress, participant enrolment, and other key metrics

Remote monitoring capabilities

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  • 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

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  • Continuous tracking of data entries and changes, allowing 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
  • It represents 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 that are useful for assessing study results.

Integrated graphical reports

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

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  • 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

SWITCH TO OOMNIA NOW.

Join us on our journey to advance clinical research together.
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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. 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

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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 ensure the highest quality, accuracy, validity, and reliability of your clinical trial data. The service encompasses thorough oversight, sophisticated analysis, review, and cleaning of clinical trial data. Discover our Risk-Based Monitoring and Source Data Review service.

Biostatistics and statistical programming

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Before the study’s commencement, biostatistical methods are used to oversee the study design 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

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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 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."

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

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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 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?

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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?

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Yes, the oomnia EDC system aligns with rigorous standards set by regulatory authorities like the FDA 21 CRF Part 11 and the EMA EU GMP Annex 11.

What are the steps in implementing oomnia EDC?

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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?

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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, 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?

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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, 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?

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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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In order to book a demo call with an oomnia expert, simply press the button below, select a date in the booking tool and fill in all necessary information. After that, we will send you an invitation.
Book a demo

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