EDC

Digitalis EDC is a web-based Electronic Data Capture (EDC) application designed for clinical data collection and management. It is built for clinical research teams who need a flexible, standards-compliant platform that can be adapted to the specific requirements of individual studies. The application runs in a standard web browser without requiring any special installation, and is accessible on desktop computers and tablets.

Digitalis is built on the Onemo framework and hosted on servers certified under the French HDS (Health Data Hosting) certification. The platform complies with FDA 21 CFR Part 11, ISO 27001, GDPR, and the CDISC ODM-XML standard, supporting audit trails, electronic signatures, secure connections, and data integrity controls throughout the data lifecycle.

Design and Accessibility

• Provides a clear, intuitive interface designed for ease of use across user types.
• Fully web-based; requires only a modern web browser (Chrome, Firefox, Safari) and an internet connection, with functional support for older browsers.
• Responsive design adapts to screen size, supporting use on both desktop computers and tablets without loss of functionality.

Compliance and Security

• Fully based on the CDISC ODM-XML standard for storing and exchanging clinical data, supporting interoperability.
• Complies with FDA 21 CFR Part 11 regulations, including secure connections, audit trails, and electronic signatures.
• Built on the Onemo framework, which is regularly audited for cybersecurity.
• Clinical data hosted on HDS-certified servers with strict security measures for health data storage and management.
• ISO 27001 certification applies to data hosting, attesting to an information security management system.
• GDPR-compliant: collects only essential personal data, audits each user account, uses no cookies except the login cookie, and provides customizable legal notices (privacy policy, cookies, terms of use).

eCRF Design and Customisation

• Includes ODM Designer, an interface for designing and modifying CRFs in compliance with the CDISC ODM-XML standard; changes are immediately deployed to the test CRF with one click.
• Supports management of protocol elements: study events, forms, item groups, items, measurement units, and code lists.
• Allows configuration of mouse-programmable consistency checks, conditions, and display options for CRF questions (additional text, hidden variables, etc.).
• Graphic customisation options include logo, colours, and platform text.
• Custom developments (additional modules, graphics) can be implemented without modifying the validated software kernel.

Study and User Management

• Supports multiple studies (Multi-CRF): each study is accessible via a dedicated URL, shares a common base of centres, countries, and users, and can be configured independently.
• Access rights management allows configuration of profiles controlling who can enter queries, manage users, and perform other actions; an exportable access rights table is available.
• Supports creation of countries, sites, and user profiles, with assignment of profiles to users.
• Multi-factor authentication supported, along with authentication via Pro Santé Connect or Pasrel/Plage.
• Multi-language support: French and English by default, with the ability to integrate any language including Chinese.

Workflows, eSignature, and Notifications

• Workflows can be configured to define conditions under which a form can be read or written, such as requiring signature of a previous form or a specific CRF field value.
• eSignature configuration specifies which forms require signature, which profiles are signatories, and the meaning of each signature.
• Notification scheduling allows configuration of sending conditions, recipients (mailing list management), contextual variables (study name, eConsent signature URL, etc.), contextual attachments (PDF of signed form, adverse event, purchase order, etc.), and email subject and body.

eConsent and Patient Engagement

• eConsent module allows authoring of consent text (which may reference platform documents) and creation of a patient quiz.
• When an eConsent is created, an email is sent to the patient to read the text and complete the quiz; the patient accesses the signature via SMS with a code entered in a dedicated interface.
• Patient signature unlocks the investigator's ability to include the patient in the study.
• ePRO functionality provides a mobile-friendly display for patients to enter their own data, with a summary of forms to complete on login and a validation message upon completion.

Data Collection and Connected Devices

• Forms are presented in an ergonomic menu and can include diagrams and instructions for investigators.
• Supports automatic data collection from medical devices via the LifeData Connect solution and the Digitalis Data Hub.
• Queries can be submitted manually by a CRA directly on the patient form or created automatically via programmed consistency checks; investigators can correct errors or provide explanations, and a dedicated module supports query management and supervision.

Compassionate Use and Early Access

• Dedicated investigator registration interface for practitioners to register, enter studies of interest, and provide site information; suitable for compassionate use and early access programmes.
• Access request management allows verification and correction of submitted information before validation, on-the-fly centre creation, and automated notification to investigators when requests are processed.

Dashboards and Reporting

• Dashboards display KPIs including inclusion curves, open centres, pending queries, and adverse events, adapted to each user profile and exportable.
• Custom supervision interfaces (diagrams, data tables, curves, pie charts) can be integrated on demand.

Additional Features

• Document management with version control, language specification, and configurable consultation rights by study, profile, and centre.
• Data export in ODM or CSV formats, including SAS import files.
• Data lock at form, patient, or global level.
• Audit trail with a dedicated, exportable module.
• Data imports for codings and CSV files.
• Annotated CRF and DVP (export of programmed queries).
• User activity logs, management of banned IPs, and logs of emails sent by the platform.
• Test environment available for user training and validation of CRF amendments.

Digitalis is offered as a per-instance subscription with monthly billing, no minimum commitment period, and no limits on the number of users or available modules. New studies can be created within an existing platform instance at reduced cost. The platform is hosted on HDS- and ISO 27001-certified infrastructure, and the Digitalis team provides configuration and adaptation services for individual study requirements.