Free Software license for academic research
Get an Exclusive Offer to Use Our Clinical Trial Software for Free
- NFree license
- NEasy to use
- NComprehensive data management
- NExceptional customer support
Free software license for academic research
Get an Exclusive Offer to Use Our Clinical Trial Software for Free
- NFree license
- NEasy to use
- NComprehensive data management
- NExceptional customer support
Enhance collaboration and efficiency in academic research with oomnia
Simplify the data collection and management process entirely with a free license
Are you tired of outdated systems and want to handle clinical trials better? Are you struggling with constrained budgets und resources? oomnia for academia is here to help you. Never miss important features again, make data inaccuracies and administrative burden a thing of the past, always get clear insights, and share data with all your team members.
oomnia for academia is user-friendly, regulatory compliant, fully connectable to other systems, and available with a free license for academic purposes.
See how oomnia can make your research easier and more effective.
EXCLUSIVE OFFER – FREE LICENSE FOR ACADEMIC RESEARCHERS
Why oomnia for academia is a great opportunity for you
See how we make academic clinical trials faster, more accurate, and easier to manage
Effortlessly improve your research process
Ideal solutions for academic institutions
Free access software solution
Is your research hindered by limited funding and resources?
Ease of use for researchers and study coordinators
Are you struggling with complicated software that slows down your research progress?
Our software is intuitive and easy to use, even for users without technical expertise. Focus on your research while our software handles the administrative burden for you.
Collaboration features for university teams
Is effective teamwork a challenge in your research efforts?
Advanced data security and compliance
Are you concerned about keeping your research data secure and compliant with regulations?
Flexibility and customizability for academic projects
Do you find it challenging to customize your research tools to fit your specific project needs?
Customize the software according to your specific research needs without any programming knowledge required. Use the web-based version or install the software on-site – flexible and according to your requirements.
EXPERIENCE OUR SOFTWARE FOR FREE
Discover how our Clinical Data Management Solution can transform your research. Academics get full access with zero license fees.
Key tools of our software for academic studies
Your all-in-one software for easy trial management
Our software consists of eight essential tools that make your clinical study management easier than ever. The system is fully interoperable, which means that it is possible to seamlessly integrate all tools to your existing systems, ensuring smooth data flow and connectivity. Only use the tools you need, what you don’t use, will not be visible. oomnia is also able to connect various digital data sources for accurate and real-time data capture.
EDC/eCRF
Precision in data management
Within oomnia, our Electronic Data Capture (EDC) tool offers comprehensive capabilities, including user-friendly configuration, controlled user access, and data integration and processing. This integration extends to IMP randomization directly within the electronic Case Report Form (eCRF) document, streamlining the data collection process. Our expert support team stands ready to assist at every step, ensuring the highest standards of data accuracy and security throughout your clinical trials. Trust oomnia for precision in data management and efficient trial execution.
eSource
oomnia has powerful eSource capabilities, which enable you to connect all other digital data sources to omnia EDC. Our software is able to capture all kinds of electronic source data in real time, such as electronic health records (EHRs), wearable technologies or mobile applications. In this way, we are ensuring highest data accuracy and enhanced clinical workflows.
RTSM
Enhancing trial efficiency
Within oomnia, our Randomization and Trial Supply Management (RTSM) module offers complete lifecycle coverage for kit shipment tracking and real-time status updates. From randomization, and allocation to treatment, as well as accountability, and end-of-trial randomization report exports, the RTSM as part of a unified system reduces manual data entry and streamlines the entire trial process by increasing transparency and eliminating needless manual reconciliation. By optimizing supply chain management and data accuracy, oomnia's RTSM tool ensures efficient and error-free clinical trials, saving time and resources for research teams.
eTMF
Streamlined document management
oomnia incorporates electronic Trial Master File (eTMF) capabilities to optimize your document management process. Benefit from real-time reports, a rapid startup timeline, and effortless document management. Our eTMF tool ensures insights into your trial's progress, and it is exportable to a fully validated eArchive for long-term data storage. Count on oomnia for comprehensive document control and efficient trial management, empowering you with convenience and confidence throughout your trials.
ePRO
Revolutionizing data reporting
Within oomnia, electronic Patient-Reported Outcomes (ePRO) emerges as a vital tool. Patients can seamlessly report their health data through smartphones, tablets, or web-based platforms, enhancing their active engagement in the healthcare process. This integration not only boosts patient involvement but also elevates data quality, delivering a more precise understanding of a patient's health. With ePRO as part of oomnia you benefit from improved communication and streamlined data collection, ultimately enhancing the quality of care.
eCOA
Elevating clinical assessments
oomnia seamlessly incorporates electronic Clinical Outcome Assessments (eCOA) for comprehensive data collection and documentation. Utilizing electronic devices such as smartphones, tablets, or web-based platforms, eCOA enhances data integrity and efficiency in clinical assessments. This integration simplifies the process, ensuring accurate and timely collection of vital clinical data, ultimately advancing patient outcomes.
eConsent
Simplifying consent processes
oomnia eConsent enables patients to choose the most convenient consent process. Our solution supports electronic as well as paper-based consent methods. It further comes with numerous features. Our tool reduces language barriers by providing consent documents in multiple languages. In addition, the interactive Q&A module allows participants to directly communicate with site staff, which gives them opportunities to raise concerns or questions. The digital signing process reduces the time needed to disseminate consent information to just three minutes.
CTMS
Elevating trial management
oomnia integrates Clinical Trial Management System (CTMS) features to enhance your trial management experience. Our platform offers customized dashboards per user role, standard study templates, and logs for efficient trial setup. With key performance indicator (KPI) reports, monitoring visit tracking, and timeline/milestone tracking, you gain full visibility into your trial's progress. Additionally, our CTMS tool covers contract management and budget/payment management, ensuring comprehensive trial oversight. Trust oomnia for streamlined and data-driven trial management that empowers you to achieve your research goals effectively.
Features of oomnia for academia
Dive more deeply into all the functions academic research needs
General Functional Requirements
One platform | oomnia has the ability to manage all databases in a single platform. |
Integrated system | Our software supplies its tools and functionalities (e.g. CDMS, KPIs, surveys etc.) within one single system. |
Process workflows | The System has the ability to manage and configure / parametrize each particular research database individually and will follow the workflow pre-defined for that database. |
Patient record identification | The System assigns a unique identifier to each patient within a project. |
Organisational scope | oomnia ensures that every research database is uniquely attributable to a single study (=clinical research project). |
Status management | Our clinical trial software ensures that edited forms are status tracked (e.g. incomplete; partially complete; done; reviewed). |
User permissions |
The System manages the user access level to perform activities (e.g. form data manipulation [i.e. create, read, update, delete], export, monitoring activities [e.g. queries, source data verification, review, etc.) depending on his/her authorizations (= rights), which will be determined by the following combined criteria:
|
Visit plan | oomnia allows that a visit plan can be specified for each study, as well as the handling of different study arms. |
Dependencies between data fields |
Our unified research software has the ability to establish dependencies of a data field on other data fields. Examples:
|
Supported data types | The System supports (but is not limited to) the following data types: numeric values, date / time, short text, long text, etc. |
Uploads / repostiory | The System has the ability to attach files of any format (non-exhaustive list includes txt, eml, docx, xlsx, pptx, pdf, jpeg, tiff, mpeg, zip, rar...) and to a study site, record or a CRF. |
Audit trail | oomnia keeps track of all auditable events on the CRF through an audit trail. An audit trail is kept for all changes to the system's configuration. |
Automatic emails | The System has the ability to automatically send email messages to concerned users in order to notify them of certain events or remind them of tasks according to pre-defined rules. |
Data concurrency | The System allows multiple end-users to access the same DB simultaneously while being able to maintain data integrity and database consistency. In particular, the System ensures that multiple users can view the same DB but only one can change it at a point in time on one single form. |
Data checks | oomnia checks data for consistency after data entry in case of invalid or missing data and inform the user through pre-defined error messages. |
Study setup by CTU | The system allows the use of all funtionalities as well as the creation and setup of new studies by CTU without the assistance of the supplier. |
Different visit types | Our system allows that visits can be defined as fix (specified sequence) or unscheduled (can be added / created at any time during the course of the study). |
GUI elements | The CDMS supports (but is not limited to) the following selectors: radio buttons, checkboxes, drop downs, calendar, catalogues, etc. |
Non-functional Requirements
Password management |
The system ensures that the password management respects the following points:
|
Web based system | The system is web based, running on all common web browsers (also older versions). |
Mobile devices | The CDMS is accessible through mobile devices (iOS, Android, Windows Phone / Mobile). Simple actions can be executed from devices. |
Responsive design | The system ensures that the GUI is optimized to the respective screen size of the device the web application is used on. |
Scalability | The System allows to expand its capacity by adding hardware resources (without need for software changes) and support increases in the number of users, data volume, and intensity of use while ensuring continuous fulfilment of all requirements. |
Local installation / hosting | It is possible to install and host the system locally at our institution. |
Bug reporting and fixing | Wemedoo provides an overview of all reported bugs and fixes critical bugs within 10 days. |
Support hours | Our technical support hours is as follows: 8-9 hours a day from Monday to Friday, if the System is fully built on CTU infrastructure (On-Premise). |
Software maintenance | We provide CTU with at least 1 major software release per year at least 3 minor release per year. |
Release roadmap | Wemedoo provides CTU on a yearly basis with an overview of planned enhancements and new features of its products and services. |
Lifecycle of the application | Our team ensures to have a system in place to inform customers about development strategy, product discontinuation, etc. |
Data backup & restore | The System generates on a daily basis a backup of the study data and allows to restore the data (on project level, i.e. a single research data base). The backups are stored for a week and data restore to any of these backuped states is possible. |
Data archiving | The System allows to archive a complete study / research data base. Archiving is possible with data export (in CDISC, PDFs of patient files, etc.). |
Data entry and reports performance | Data entry screens and reports are swift to load (Test with 3000 patients) and complete in < 2 Min, also with complex queries / SQL statements. |
Database configurability | The System has the ability to create and modify research databases as per study specific requirements. The number of study databases is not limited. |
Data fields configurability | oomnia has the ability to create and modify data fields of any formats as per study requirements. The number of data fields is not limited. |
Electronic forms configurability | The System has the ability to create and modify the electronic forms for study data entry as per study requirements. It is possible to structure each electronic form by adding / removing user-input elements (fields, radio buttons, check lists, long texts, matrix of items, etc.). The number of electronic forms is not limited. The number of elements in an electronic form is not limited. |
Visit configurability | The System has the ability to create and modify repeating visits as well as unscheduled visits. |
Ease of upgrade / update | Our software ensures that the upgrade/update to newer product versions can be completed in a secure and reliable manner, with minimal effort and with support from the supplier if needed (e.g. by providing an upgrade/update script). |
Clear purpose | The system's functions are easy to use and understand. |
Role- and workflow-driven adaptation | oomnia optimizes the GUI by enabling / disabling its elements according to the end-user authorizations on the database requirements. |
User preferences | The System allows the user to adjust GUI layout and functions (e.g. language settings, preferred reports, etc.) to suite personal preference and store these adjustments for subsequent sessions. |
Learnability | Processes and functionality are easy to learn and remember. After a short training, the end-users shall be able to complete all the activities under their responsibility with minimal need of support. |
Useful error messages | Our software provides error messages for validation, verification, or run-time problems. The error messages are useful and indicate how to resolve the problem. |
Look & feel | The System provides an attractive layout and color scheme, which make the screens pleasurable to look at. |
Character sets | oomnia uses character sets which cover all the languages for which data will be gathered and stored (e.g. Unicode). |
System language | The System’s GUI is available in the following languages: English, German, and French. |
Documentation | Wemedoo provides documentation in English for training of end-users and System administrators. |
Training | Our team trains CTU personnel on System Administration and end-user functionality. |
Supplier auditability | Wemedoo agrees to be audited by CTU throughout the lifecycle of the software products and / or services provided. |
Data Management Requirements
Multicenter capability | The system supports the implementation of multicenter studies (i.e. data entry only sees local data, PI sees all data of the study, access data of parts of centers, manage multicentric patient). |
Study setup by pi | oomnia enables the setup by PIs without the assistance of CTU or the supplier. |
Blinding of the study | The system allows for blinding of the whole study. |
Emergency unblinding | Our software allows for emergency unblinding. |
Classification codes | The CDMS supports the addition of classification codes (e.g. ICD-10, ATC etc.). |
Copy-paste | The system enables the copying of entire implementations from an existing study database into a new study database. |
Data validation | Our CDMS offers a function to define the validation of data fields in order to ensure that entered data complies with a given format (e.g. such as date DD/MM/YYY, number, letters only etc.). |
Data validation plan | oomnia supports the creation of a data validation plan (containing all edit-checks to be performed on the collected data) within the system. The system enables the verification of the defined data validation plan. |
Plausibilty checks | The system has the ability to perform plausibility checks (i.e. cross-checks between data entry fields in order to avoid obvious contradictions). |
Plausibility / edit checks | The software supports the definition of edit checks which can be defined for data entry fields (i.e. the system allows the definition of mandatory fields, range checks, cross field/forms check, complex consistency checks, etc.) |
Saving of erroneous eCRF | The system has two levels of plausibility checks: Strong (error) and soft checks (warning). |
Adaptation of productive studies | The system supports the addition of new eCRFs in productive studies. It supports the addition, hiding or disabling of individual fields to an eCRF in productive studies. The system does not allow for changes that lead to inconsistencies in the database. |
Traceability | All modifications of the eCRF are traceable. |
Identifying data | The system provides the option to mark identifying variables. |
Data validation | The system runs validation rules along with proposed changes. It does not allow incongruent rules to be implemented. |
Freezing | Our system supports the freezing/locking of individual forms in the database upon completed data entry (via admin login; performed manually). |
Database lock | oomnia supports the freezing (i.e. no data can be entered or edited anymore unless the database is unlocked again) of the entire study database. |
Development and production environment | The system provides a separated development and productive environment. |
Database deployment | Our clinical trial system supports the deployment of the database from the development to the productive environment. |
Double data entry | The system allows for the (form-specific) configuration of a double data entry workflow. |
eCRF wizard | The system supports the intuitive creation of eCRFs (i.e. wizard or GUI). |
eCRF layout wizard | oomnia allows the structuring and organization of items / spaces within the eCRF. |
Printing | All eCRFs within the system are printable. |
Repetitions / sub-entities | Our CDMS allows to define elements (i.e. single items, groups of items, whole forms, etc.) that can be repeatedly filled out as many times as necessary. |
Branching logic | Our software allows for an intuitive implementation of a branching logic (i.e. the function to show/hide certain fields under a given precondition). |
Multi-lingual setup | The system allows for the assignment of different labels to the same item or default value (i.e. one per language used in the study). |
Surveys / patient reported outcomes | Our software offers the possibility to create surveys (i.e. online data entry forms which can be accessed via any browser without login) which can be sent directly to a given patient. |
Calculated fields | Our system allows the configuration of calculated fields (e.g. score calculations based on other data entry fields etc.). |
Blinding of individual roles | oomnia allows for blinding of individual user roles. |
Export of blinded PDF | The system provides the option to extract blinded PDFs (per patient or all patients; complete data or only specific forms, e.g. for adjudication). |
Data Entry Requirements
Web based data entry | The system supports data entry via online forms. |
Time till automatic log off | The system indicates the delay before the system automatically logs the user off. |
Interface | oomnia provides a simple and intuitive data entry interface. |
Missing data | The software offers a mechanism for the handling of missing data. |
Queries | The system allows for queries to be answered by correcting/changing the data and writing a reply. All items that are linked to the queried item through branching logic shall be editable. |
Form completion status | The system supports the manual as well as the automatic marking of a form as complete / incomplete / etc.. |
User warnings | Our software issues user warnings before navigation if this were to lead to a loss of data. |
eCRF completion status overview reports | The CDMS contains overview reports for the tracking of CRF completion status. |
Data saving | The system offers the possibility to save the entered data at any time. |
Navigation | The system provides a simple and intuitive way for data entry personnel to navigate the system (e.g. to go from one form to the next, or to go from a form back to the visit plan and vice versa). The user is aware of where he is located and where he can navigate to. |
Comments | oomnia allows additional comments at the level of an item. |
Monitoring Requirements
Erroneous forms | Our software tags erroneous forms so that they can be recognized without having to open the form. |
Deviation reporting | The system allows the reporting of deviations on different levels (e.g. form, visits, item, patient, etc.). |
Query creation | oomnia supports the creation of queries (item-, form-, visit-, patient-based). |
Query workflow | The system allows for queries to be created and closed by the monitor. |
Study progress report | The software provides a report of study progress key performance indicators (e.g. overall recruitment status, recruitment status per study center, patient status, etc.). |
Query overview reports | The system contains overview reports for query management. There should be a direct link from the query list to the form concerned (i.e. by clicking on a query in the query list, you jump directly to the form / data filed for which the query was raised). |
(S)AE notification | Expedited notification about reported (S)AEs via email, with link to reported event. |
Source data verification | oomnia supports the process of source data verification (SDV) by allowing to report the SDV status for a given data point or an entire form (= massaction). If data points are altered after SDV had already been done (and status set to SDV), the SDV status changes to not SDVd. |
Statistical Requirements
Randomization module | The system supports integrated randomization (standard randomization algorithms, advanced algorithms like minimization). |
Upload of external randomization lists | oomnia supports the upload of an external randomization list (alternative randomization / stratification scheme). |
Data export | The system supports the exportation of data by CTU or system users (export rights defined in role). The Export file contains meta data such as variable and code labels. |
Identifying data | Our software provides the option to hide identifying data on a variable level when exporting data. |
Configurable data export | The system contains a feature to exclusively export monitored / reviewed data. |
Data export formats | oomnia allows the export in data formats csv and xlxs. |
Report creation | Our system has the ability to create and modify reports of different types and using both standard data fields, customized data fields (e.g. calculations) and status indicators (e.g. SDV, review status, etc.) or metadata as per study requirements. The number of reports is not limited. |
Graphs creation | The System has the ability to create and modify graphs of different types and using both standard and customised data fields as per study requirements. The number of graph tools is not limited. |
Reports | oomnia includes a feature to make reports available to specified user roles only. |
Data quality reports | The system allows the creation of customized data quality reports (i.e. in order to detect missing data, incomplete forms etc.). |
Regulatory Requirements
Validation | System Validation documentation and Reports based on Risk Assessment are approved and available. |
Validation standards | The Validation Process for the System is defined according to pre-defined standards (e.g. Policy, Procedures) and covers all the relevant steps of the system life cycle. |
System inventory | The System is included in an up-to-date inventory listing of all relevant systems. |
Supplier qualification | Wemedoo ensures that the System has been developed in accordance with an appropriate quality management system. |
User requirements | User Requirements Specifications describing the required functions of the System are present and traceable throughout the lifecycle. |
Validation testing | Evidence of appropriate test methods and test scenarios are demonstrated. Particularly, System (process) parameter limits, data limits and error handling are considered. |
Incident log | All incidents, not only System failures and data errors, are reported and assessed. The root cause of a critical incident is identified and should form the basis of corrective and preventative actions. |
System change control | Any changes to the System, including system configurations, are made in a controlled manner in accordance with a defined procedure. |
Invalid record detection | The System allows to discern invalid records. |
Interface built-in checks | In case the System exchanged data electronically with other systems, it includes appropriate built-in checks for the correct and secure entry and processing of data, in order to minimise the risks. |
Operational checks | oomnia has operational checks in order to enforce permitted sequencing of steps and events, by allowing the execution of one step only after the execution of the previous one (this requirement applies only if particularly critical operations are performed through the System). |
Accuracy checks | oomnia ensures accuracy checks for manually entered critical data through additional verification by a second operator or validated electronic means. This includes reviewing data management records. The system incorporates risk management to address the criticality and potential consequences of erroneous or incorrectly entered data. |
Backup | Backup and recovery procedure are defined where temporal periods for data backup are defined. Regular backups of all relevant data can be done. Integrity and accuracy of backup data are monitored periodically. |
Data restore | The ability to restore the data is checked during validation and monitored periodically. |
Data retention | Data is secured by both physical and electronic means against damage. |
Business continuity | Provisions is made to ensure continuity of support for critical processes in the event of a system breakdown (e.g. a manual or alternative system). The time required to bring the alternative arrangements into use is based on risk and appropriate for a particular system and the business process it supports. These arrangements are adequately documented and tested. |
Restricted access | The System restricts access to pre-authorised users. |
Restricted use | The System restricts use of its functions according to pre-configured user profiles that are maintained. Any changes to the roles are authorised and tracked. |
User profiles security | Creation, change and cancellation of access authorisations and user profiles (i.e. functions users are able to use) are traced according to a pre-defined procedure. |
Password assignment | Password is known only by the user. When a new password is assigned by the System administrator, the System forces user to change his password after the first login. |
Automatic log off | The System includes a log off mechanism after a pre-defined period of user inactivity, or a mechanism where user ID entry is required after inactivity period. |
Username & code control | oomnia ensures that identification code and password are periodically checked, recalled, or revised. |
Access denied | The System electronically de-authorises access when an incorrect combination of identification code and password is repeated a defined number of times. Re-assignment of password is managed by an adequate procedure. |
Unauthorised access detection | Our software detects and reports in an immediate and urgent manner any attempts at unauthorised use of identification codes and password to the System security unit, and, as appropriate, to organisational management. |
Uniqueness of codes | oomnia maintains the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. |
Temporal reference | The System ensures that the time reference is equal for all users, or automatically synchronises all work stations. The System not allows the users to change the time reference. |
Record audit trail | System Audit Trail, based on a risk assessment, tracing all relevant GCP changes, and deletion is in place through automatic functionality. Audit Trail records operators are creating, changing, confirming or deleting data, including date and time, ensuring that previous record changes are not overwritten. Audit trail documentation is retained throughout the records retention period. |
Audit trail copy | The System allows to create accurate and complete copies of audit trail in a standard file format (e.g. PDF…). |
Audit trail review | Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed. |
Supplier Profile Requirements
Quality management systems certification | Wemedoo (including affiliates and subcontractors) works at all times according to ISO 9001 certification, GCP (Good Clinical Practice), GDPR or any other standard relevant to the applicable scope of the agreement. |
Compliance with GAMP® 5 | Our team has a QMS (Quality Management System) and a product development lifecycle complying with computerized systems and engineering best practices described in GAMP® 5. |
Initial costs | We give an approximation of initial setup costs for one installation. |
Annual costs | Our team describes how annual costs are calculated for a single customer. |
Licence model | Our team describes the applied licence model. |
Database management system used | We describe what kind of database management system we use (e.g. SQL, etc.). |
ENHANCE RESEARCH WITH OUR FREE LICENSE SYSTEM