Main dashboard
A general dashboard displays the important figures and events of the study. Its contents depend on the rights of the connected user.
Inclusion curve
The inclusion curve is an essential dashboard to track the progress of inclusions.
Custom dashboards
We implement relevant dashboards for your study: lists of adverse events, summary tables, graphs of all types (histograms, pie charts, etc.)
Receive relevant notifications by email: reporting of serious adverse events, or other important events of your study.
Data Management
ODM Designer (Study Design)
The design of your studies can be done with the integrated study design solution: ODM Designer. Easy to use and intuitive, it allows you to create your studies or to make amendments to the CRF in compliance with the standard CDISC ODM-XML. ODM Designer is fully integrated with Digitalis: in a few clicks, changes made in ODM Designer can be put into production.
Advanced consistency checks
Create complex consistency controls in xQuery, the XML data manipulation language.
Forms design
Digitalis forms are customizable via XSL sheet editing. Adapt their layout, integrate images or web components.
Export data
Export patients' CRFs and annotated CRFs.
Export clinical data in CSV format, define your partial or complete export.
Export raw clinical data in CDISC ODM-XML format.
Manual Queries
As a Clinical Research Associate, you have the option of submitting queries on patient forms. When a query is opened, it is submitted to the investigator who has the opportunity to correct the error or explain the reason for the inconsistency. If the problem is resolved, the query can be closed. If not, it may be resubmitted to the investigator.
Automatic Queries
When data is forgotten or incorrectly entered by the investigator, Digitalis raises an automatic query, warning the investigator. The investigator has the opportunity to correct his error or explain the reason for the inconsistency. In the second case, the query will be submitted to the validation of a clinical research associate to be closed or resubmitted to the investigator.
Management module
The CRAs have access to a complete management module for all queries. It is possible to open, close, or respond to queries to justify a request for correction to an investigator.
Identify deviations from the protocol on patient forms. A module is also dedicated to the overall management of deviations.
Post its
You have the option to post electronic notes on patient forms to send a message to the investigators.
Compassionate use
User access requests
The investigators wishing to join the study can make access requests. Project managers can validate these requests through a dedicated interface.
Validation and monitoring of treatments
A project manager electronically signs requests for patient inclusion and controls treatment shipments.
Emails are sent to users, project managers, investigators, etc. for example to inform them of a request for access or a validation of treatment supply.
Web application
Digitalis can be used with a web browser: Chrome, Mozilla, Safari, Opera, Internet Explorer 9 and higher.
Digitalis can be used on tablet and computer. It adapts to the size of your screen.
Digitalis uses smooth Ajax navigation to limit page reloads and increase the speed of navigation.
Norms and standards
Clinical data are recorded in XML format and are subject to the CDISC ODM validation scheme. The business logic of Digitalis is fully designed to meet this standard. This is a guarantee of quality. At any point in the study, you have the option to export or import clinical data in ODM-XML format.
FDA 21 CFR Part 11
Audit trails
The details of all data changes are recorded in the database, ensuring their traceability.
User identification.
Access is restricted to authorized users, access rights apply to all Digitalis features. Users are disconnected automatically after a defined period of inactivity.
Electronic signature
Digitalis makes it possible to ensure the identity of the user at each important step of the data entry by proposing an electronic signature system.
Paper version
Data can be used or archived in paper format or equivalent using PDF export functions.
Management of centers, user accounts and their profile.
Clinical data
Imports of clinical data in ODM-XML format, possibility of specific imports.
Freezing of data
Select the data to lock for partial or full study freeze.
Maintenance mode (automatic user disconnection and application blocking), technical aspects of the application