Features

Launch new studies within the same platform, sharing common base elements like centers, countries, and users. Independent configuration of study parameters such as ePRO, informed consent, forms, and workflows.

Digitalis integrates ODM Designer, an intuitive solution for designing and modifying CRFs, compliant with the CDISC ODM-XML standard. With one click, changes made in ODM Designer are immediately deployed to the test CRF. Manage protocol (study events, forms, item groups, items), measurement units, code lists, mouse-programmable consistency checks, conditions, options for displaying questions in CRF: additional text, visibility (hidden variables), etc. Easily copy a part of a study to another study. The Annotated CRF button allows you to export the structure of the form into a PDF file. This export includes detailed information such as visits, forms, item groups, items with their corresponding CDISC OIDs, and the associated codelists. This feature ensures that all study data is well-documented and easily accessible in a structured format, making it ideal for compliance, auditing, and review purposes. This document can also be very useful for statistical analysis.

Define conditions for when forms can be read or written (e.g., signature of previous forms). Specify which forms require signatures and define the profiles and meaning for each signature.

Customize the subjects list by modifying column content. Define title, data type (e.g., crf field, visit status, form status etc), enable sorting and searching.

Schedule notifications with customizable sending conditions, recipients, and contextual attachments (e.g., signed forms or adverse event reports). Include dynamic variables like study name and eConsent URLs in emails for a tailored communication experience. Manage mailing list to be used in your notifications. Review all emails sent by the platform, providing a record to ensure that messages have been delivered successfully. This helps in tracking communication and confirming email delivery.

Patients can sign eConsent documents through SMS codes, unlocking their ability to be included in the study. Patients can enter data using a mobile-friendly interface. Upon logging in, a summary of forms to be completed is displayed, and validation messages confirm the completion of tasks. Using our LifeData Connect solution, add your equipment to the Digitalis Data Hub and automatically collect data from medical devices.

Configure access rights for different profiles: who can enter queries? Who can manage users? Access a comprehensive, exportable access rights management table to assign profiles to rights. Create countries, specify the studies concerned by these countries, create sites, assign profiles to your users.

Organize and manage documents, specifying titles, versions, languages, and consultation rights.

Practitioners register via a dedicated interface, select the study(s) of interest and information from their site. This feature is appropriate for compassionate and early access programs. Verify and correct the information received before validating requests. Create centers on the fly if necessary, notify investigators when their request is processed.

Tailor dashboards to the study’s needs, displaying KPIs, inclusion curves, and adverse events. Dashboards are updated in real-time, and data is exportable to various formats (e.g., CSV, PDF, XML).

Clinical Research Associates (CRAs) can submit queries directly on patient forms or via automatic triggers. A complete management module enables opening, responding to, and closing queries efficiently.

Maintain a complete audit trail of all data changes for traceability. Access a dedicated, exportable module that tracks all actions made on data, including who performed the action, when it occurred, and why it was done. This ensures full traceability and compliance throughout the study.

Lock data to prepare for study freezes, either partially or globally.

Export data in CSV and XML formats, with the ability to customize partial or complete data exports. SAS import files are also generated to help you load the data in SAS.

Build your own eCRF to suit study-specific requirements, with full autonomy over design, graphics (logo and colors), access controls, legal texts and more. Digitalis focuses on technological innovation to provide tailored solutions, enabling you to create custom modules and graphics without affecting the validated core software.

Digitalis operates smoothly on popular web browsers and is compatible with both tablet and desktop devices. Adapts to screen size for seamless navigation across devices. Smooth Ajax navigation reduces page reloads, improving speed and usability.

Secure user access with multi-factor authentication options. Digitalis ensures full compliance with FDA 21 CFR Part 11 and CDISC ODM-XML, providing audit trails, user identification, and electronic signatures.

French and English are default, additional languages are available and can be used to support global studies.

Custom CRF forms, workflows, and notifications can be tailored to meet study-specific needs. The platform's API layer enables Digitalis to be integrated with any other third-party system. Test environments and user training modules allow for pre-launch testing and validation of CRFs.