Oomnia EDC/CTMS.
An integrated solution designed for all clinical trial types and organizations regardless of their size.
Oomnia® is built to support multiple trials on a single instance of the system, meaning that all your studies and associated documents will be on one platform.
You can access multiple trials simultaneously while having different roles with different permissions and access system modules, documents, and reports across the trials, all with one simple login.
Your teams need no set-up and document creation training. We build any type of EDC form or document according to your needs and provide you with a turnkey solution.
IWRS & Randomization
Oomnia EDC/CTMS system has an advanced Interactive Web Response System (IWRS) that facilitates randomization and trial supply management. Through this module, the user can:
- Send and receive IMP shipments.
- Upload and view IMP lists.
- Upload and view the randomization list.
- View randomization status and perform unblinding.
Oomnia is preprogrammed with the most common randomization schedules, including:
- Simple randomization is the simplest and most frequently used algorithm. It can result in an imbalance between the groups, however with the large number of iterations our system can perform, it can usually provide the desired allocation ratio.
- Random Sorting is applicable for any allocation type and any number of trial arms. This type of randomization can result in a significant imbalance in subject allocation throughout the randomization process. Still, in the end, it results in assignments that match the target groups.
- Random Sorting Using Maximal Allowable Percent Deviation is similar to the random sorting algorithm however, the percentage of deviation at any point during the allocation process is limited by users’ specification.
- Efron’s Biased Coin is only applicable for studies with two arms. It achieves longitudinal balance (dynamic changes of allocation probabilities) with a user-specified probability parameter.
- Smiths’s randomization is only applicable in studies with two arms. It achieves a longitudinal balance (dynamical changes of allocation probabilities) with a user-specified exponent parameter.
- Wei Urn randomization can be used in studies with two or more arms. It achieves longitudinal balance (dynamical changes of allocation probabilities) with a user specified A and B parameters.
Additionally, we support most any type of block randomization and stratification schemas that your study may require. Depending on your study needs, it is possible to:
- Program additional randomization methods not listed above
- Automatically allocate patients to treatment arms using the appropriate randomization methods
Electronic Data Capture
eCRFs are the core EDC functionality of any clinical trial data management system. Oomnia® incorporates advanced eCRF options, including rapid eCRF creation, validation, in-trial change, and export, among many others.
With Oomnia®, your teams need not be trained to create eCRFs in a foreign system. We take eCRF creation out of your hands and offer a turnkey solution. Our data management experts work with you personally to create your eCRF, validate it, and stand behind our work with our industry-leading support.
- Multiple simultaneous trial-specific user permission settings
- Rapid eCRF/EDC document creation
- In-trial eCRF changes (minutes to hours)
- Automatic eCRF Form export (single page or entire form)
- Rule and formula editor
- Custom calculate fields
- Automatic triggers, query generation and assignment
- Automatic discrepancy detection
- Double data entry (DDE)
- Upload of any type of data file
- Notes, comments, queries on any document field (with history)
- Detailed granular access control for each document type
- Full audit trail and history of changes
- CDASH and SDTM variable names for all applicable data points
Oomnia® EDC/CTMS system has been constructed so that any and all EDC forms created have the same functionalities as eCRFs by default.
Patient Reported Outcomes
Patient Reported Outcomes (PRO) are increasingly important. Whether they are questionnaires, patient diaries, or data from wearable devices, our system can handle it all. For Oomnia® EDC/CTMS, WebPRO is not a special system module rather a natural inherent extension of the EDC system. As such, it runs on any web browser, on any device, and in any language. All that is required is an internet connection and no special software. Our system can be adapted to integrate data from almost any wearable device.
- Use on any device including computer, tablet, or smartphone
- Simple user interface
- Subject account management
- Reminders and notification emails
- Role-based permissions for the visibility of personally identifiable information
- Simple question
- Integration of data from wearables
Query Management
Oomnia® EDC/CTMS has a dedicated Query Manager Module, which gives a detailed overview of all queries that a user has the right and permissions to either view, ask, respond to, or close. The Query Manager lists all queries and their details, including query type, trial, investigational center, instance (patient) ID, query location, and creator, as well as the date of the last change and full query history. Clicking on the query location directly opens the exact eCRF and document field (query location). Additionally, our system automatically tracks time to answer, resolve, and close a query.
- Automatic query generation based on predefined field rules and triggers
- Automatic query addressing
- Full query history
- Addition of notes to a query
- The ability to comment on a query and address the comment to a user
- Conversational comment thread
- Detailed query management
- Query metrics
Custom Reports
Following your requirements, Oomnia® EDC/CTMS can be tailored to provide custom on-demand reports. The reports can be programmed to provide comparisons and metrics for and between sites, countries, or the entire study. Some custom reports include:
- Recruitment, enrolment, and randomization
- Study withdrawal and completion
- Treatment compliance
- Medical history
- Concomitant medication
- AE and SAE reports
- Query aging and resolution
- Major and minor protocol deviations
Custom reports can be programmed to not only consider data from the eCRF but from other EDC forms like patients reported outcomes (PRO), electronic monitoring visit reports (eMVR), subject logs, site staff and responsibility logs, for any other EDC documents created with our system.
Trial & Document Management
Oomnia® EDC/CTMS enables complete collaborative study management by having all administrative forms such as visit reports and study logs available in a single cloud-based system.
Our team can create any type of EDC form, including visit report forms, logs, or any other form that your trial may require. The flexibility of the system means that you do not use predefined forms, rather our expert staff works with you to create exactly the tools that you need for your organization-specific workflows.
Data in any form created in Oomnia® is handled in the same manner as eCRFs, thus providing the same level of security, accountability, data review, communication, and analysis as an actual eCRF.
- User, site, organization, and trial administration
- Granular document, site, and trial-specific user permissions for all EDC and read only documents uploaded to the system
- Site and staff management
- Reports - site initiation, visit, close-out
- Logs – site staff and responsibility, temperature, transport, etc.
- Upload of any read-only document
- .pdf, .doc, .xlxs, etc.
- Contracts, letters, regulatory filings, insurance
The ability to upload and control the access permissions for any read-only document, enables Oomnia® EDC/CTMS to be the place for all your clinical study data, from eCRFs, to reports, to the entire eTMF (custom build). Why use and learn multiple systems when, with Oomnia® EDC/CTMS, your team has the access to all the documents they will ever need in one convenient location.
IWRS & Randomization
Oomnia® EDC/CTMS system is preprogrammed with the most common randomization schedules, including:
- Simple randomization is the simplest and most frequently used algorithm. It can result in an imbalance between the groups, however with the large number of iterations our system can perform, it can usually provide the desired allocation ratio.
- Random Sorting is applicable for any allocation type and any number of trial arms. This type of randomization can result in a significant imbalance in subject allocation throughout the randomization process. Still, in the end, it results in assignments that match the target groups.
- Random Sorting Using Maximal Allowable Percent Deviation is similar to the random sorting algorithm however, the percentage of deviation at any point during the allocation process is limited by users’ specification.
- Efron’s Biased Coin is only applicable for studies with two arms. It achieves longitudinal balance (dynamic changes of allocation probabilities) with a user-specified probability parameter.
- Smiths’s randomization is only applicable in studies with two arms. It achieves a longitudinal balance (dynamical changes of allocation probabilities) with a user-specified exponent parameter.
- Wei Urn randomization can be used in studies with two or more arms. It achieves longitudinal balance (dynamical changes of allocation probabilities) with a user specified A and B parameters.
Additionally, we support most any type of block randomization and stratification schemas that your study may require. Depending on your study needs, it is possible to:
- Program additional randomization methods not listed above
- Automatically allocate patients to treatment arms using the appropriate randomization methods
Please, contact us for more information and features.
Electronic Data Capturing
eCRFs are the core EDC functionality of any clinical trial data management system. Oomnia® incorporates advanced eCRF options, including rapid eCRF creation, validation, in-trial change, and export, among many others.
With Oomnia®, your teams need not be trained to create eCRFs in a foreign system. We take eCRF creation out of your hands and offer a turnkey solution. Our data management experts work with you personally to create your eCRF, validate it, and stand behind our work with our industry-leading support.
- Multiple simultaneous trial-specific user permission settings
- Rapid eCRF/EDC document creation
- In-trial eCRF changes (minutes to hours)
- Automatic eCRF Form export (single page or entire form)
- Rule and formula editor
- Custom calculate fields
- Automatic triggers, query generation and assignment
- Double data entry (DDE)
- Upload of any type of data file
- Notes, comments, queries on any document field (with history)
- Detailed granular access control for each document type
- Full audit trail and history of changes
- CDASH and SDTM variable names for all applicable data points
Oomnia® EDC/CTMS system has been constructed so that any and all EDC forms created have the same functionalities as eCRFs by default.
Patient Reported Outcome
Patient Reported Outcomes (PRO) are increasingly important for all types of studies. Whether they are questionnaires, patient diaries, or data from wearable devices, our system can handle it all. For Oomnia® EDC/CTMS, WebPRO is not a special system module rather a natural inherent extension of the EDC system. As such, it runs on any web browser, on any device, and in any language. All that is required is an internet connection and no special software. Our system can be adapted to integrate data from almost any wearable device.
- Use on any device including computer, tablet, or smartphone
- Simple user interface
- Subject account management
- Reminders and notification emails
- Role-based permissions for the visibility of personally identifiable information
- Simple question
- Integration of data from wearables
Query Management
Oomnia® EDC/CTMS has a dedicated Query Manager Module, which gives a detailed overview of all queries that a user has the right and permissions to either view, ask, respond to, or close. The Query Manager lists all queries and their details, including query type, trial, investigational center, instance (patient) ID, query location, and creator, as well as the date of the last change and full query history. Clicking on the query location directly opens the exact eCRF and document field (query location). Additionally, our system automatically tracks time to answer, resolve, and close a query.
- Automatic query generation based on predefined field rules and triggers
- Automatic query addressing
- Full query history
- Addition of notes to a query
- The ability to comment on a query and address the comment to a user
- Conversational comment thread
- Detailed query management
- Query metrics
Custom Reports
Following your requirements, Oomnia® EDC/CTMS can be tailored to provide custom on-demand reports. The reports can be programmed to provide comparisons and metrics for and between sites, countries, or the entire study. Some custom reports include:
- Recruitment, enrolment, and randomization
- Study withdrawal and completion
- Treatment compliance
- Medical history
- Concomitant medication
- AE and SAE reports
- Query aging and resolution
- Major and minor protocol deviations
Custom reports can be programmed to not only consider data from the eCRF but from other EDC forms like patients reported outcomes (PRO), electronic monitoring visit reports (eMVR), subject logs, site staff and responsibility logs, for any other EDC documents created with our system.
Trial & Document Management
Oomnia® EDC/CTMS enables complete collaborative study management by having all administrative forms such as visit reports and study logs available in a single cloud-based system.
Our team can create any type of EDC form, including visit report forms, logs, or any other form that your trial may require. The flexibility of the system means that you do not use predefined forms, rather our expert staff works with you to create exactly the tools that you need for your organization-specific workflows.
Data in any form created in Oomnia® is handled in the same manner as eCRFs, thus providing the same level of security, accountability, data review, communication, and analysis as an actual eCRF.
- User, site, organization, and trial administration
- Granular document, site, and trial-specific user permissions for all EDC and read only documents uploaded to the system
- Site and staff management
- Reports - site initiation, visit, close-out
- Logs – site staff and responsibility, temperature, transport, etc.
- Upload of any read-only document
- .pdf, .doc, .xlxs, etc.
- Contracts, letters, regulatory filings, insurance
The ability to upload and control the access permissions for any read-only document, enables Oomnia® EDC/CTMS to be the place for all your clinical study data, from eCRFs, to reports, to the entire eTMF (custom build). Why use and learn multiple systems when, with Oomnia® EDC/CTMS, your team has the access to all the documents they will ever need in one convenient location.
Intuitive
Boost your staff's performance by allowing them to navigate through the complexity of their tasks with ease and clarity. Oomnia® is a robust system that provides intuitive, easy-to-use resources and facilitates the performance of any clinical trial, no matter how small or large.
Rapid Deployment
Meet your deadlines comfortably by setting up your study in a matter of days, not weeks. Our Oomnia® EDC/CTMS solution facilitates rapid eCRF creation, and it allows you to conveniently make mid-study eCRF changes in a matter of minutes to hours.
Flexible
Advance your workflows by tailoring your operating platform according to your trial needs. Oomnia® is simple to use and can be fully customized to your business processes. With its built-in flexibility, our system can accommodate multiple studies, users, sites, schedules, and track operational changes seamlessly.
Accessible
Fast-track your work progress by accessing your trials anywhere. With Oomnia®, you can simultaneously track multiple trials on every device and every browser. The system can synchronously support multiple languages, with user-level adjustability.
User-centered
Automate your work processes by enabling your staff to track multiple activities with a single login. With Oomnia® EDC/CTMS, each user can have access to multiple trials with different roles with different permissions, while having access to system modules, documents, and reports across multiple trials.
Expert Support
When performing trials with Oomnia®, you will have access to a dedicated service specialist. You can use our expertise all along the way to the final CSR, and we’ll make the entire process easy, smooth, and cost-effective.
