Digitalis

Digitalis is a web-based electronic data capture (EDC) software platform designed for clinical data collection. It serves clinical research teams, investigators, and study coordinators by providing tools to design, manage, and monitor clinical studies, including support for ePRO, eConsent, connected medical devices, and regulatory compliance workflows.

The platform operates as a dynamic, browser-based application compatible with both desktop and tablet devices, and is built around CDISC ODM-XML standards. It supports multiple concurrent studies within a single platform instance, sharing common infrastructure such as centers, countries, and user accounts while allowing independent configuration per study.

Study Design and CRF Management

• Supports multi-CRF management, allowing new studies to be launched within the same platform while sharing base elements like centers, countries, and users.
• Each study can be independently configured for parameters including ePRO, informed consent, forms, and workflows.
• Includes ODM Designer, an integrated tool for designing and modifying case report forms (CRFs) that is compliant with the CDISC ODM-XML standard; changes made in ODM Designer are immediately deployed to the test CRF.
• CRF design covers study events, forms, item groups, items, measurement units, code lists, consistency checks, conditions, and display options such as hidden variables and additional text.
• Supports copying parts of a study to another study for reuse of design elements.
• Annotated CRF export generates a PDF containing visits, forms, item groups, items with CDISC OIDs, and associated codelists, suitable for compliance, auditing, statistical analysis, and review.

Workflows, eSignatures, and Notifications

• Form access control allows conditions to be defined for when forms can be read or written, such as requiring the signature of a previous form.
• eSignature management enables specification of which forms require signatures, along with the profiles and meaning associated with each signature.
• Automated notifications can be scheduled with customizable sending conditions, recipient lists, and contextual attachments such as signed forms or adverse event reports.
• Notification emails support dynamic variables including study name and eConsent URLs.
• Mailing lists can be managed for use across notifications, and a mail log provides a record of all emails sent by the platform to confirm delivery.

eConsent, ePRO, and Connected Devices

• eConsent functionality allows patients to sign consent documents via SMS codes, which then unlocks their inclusion in the study.
• ePRO support provides patients with a mobile-friendly interface; upon login, a summary of forms to be completed is displayed, and validation messages confirm task completion.
• Connected device integration is available through the LifeData Connect solution, which links medical equipment to the Digitalis Data Hub for automatic data collection.

Access Rights and User Management

• Access rights can be configured per profile, controlling actions such as entering queries or managing users; a comprehensive, exportable access rights management table is available.
• Administrators can create countries, assign studies to countries, create sites, and assign profiles to users.
• Subject list views are customizable, with configurable columns for data type, visit status, form status, and sorting and searching options.

Document Management and Investigator Registration

• Study documents can be organized and managed with attributes including title, version, language, and consultation rights.
• An investigator registration interface allows practitioners to register, select studies of interest, and provide site information; this feature is designed for compassionate use and early access programs.
• Administrators can review and correct registration information before validating requests, create centers on the fly, and notify investigators when their requests are processed.

Dashboards and Data Monitoring

• Custom dashboards can be configured per study to display KPIs, inclusion curves, and adverse events, with real-time data updates.
• Dashboard data is exportable in formats including CSV, PDF, and XML.
• Clinical Research Associates (CRAs) can submit queries directly on patient forms or via automatic triggers; a complete query management module supports opening, responding to, and closing queries.
• A full audit trail module tracks all data changes, recording who performed each action, when it occurred, and the reason, with export capability for compliance purposes.
• Data locking supports partial or global study freezes in preparation for data lock.

Data Export

• Data can be exported in CSV and XML formats, with options for partial or complete exports.
• SAS import files are generated to facilitate loading data into SAS for statistical analysis.

Custom eCRF and Usability

• Custom eCRF design allows study-specific builds with full control over design elements including logo, colors, access controls, and legal texts, without affecting the validated core software.
• The platform runs on popular web browsers and is compatible with tablet and desktop devices, with responsive design that adapts to screen size.
• Ajax-based navigation reduces page reloads to improve speed and usability.
• Security features include multi-factor authentication.

Digitalis is positioned as a configurable EDC platform suitable for a range of clinical study types, including standard interventional trials, compassionate use programs, and patient-reported outcome studies, with an emphasis on CDISC compliance, traceability, and adaptability to study-specific requirements.