Ividata Group
“It's clear, it's well put together, it looks good and it's easy to use.”
eCRF · 21 CFR Part 11 · CDISC ODM-XML · HDS · GDPR
Clinical data collection.
Finally frictionless.
Digitalis is a web-native EDC platform designed for regulatory and clinical teams. User-friendly, compliant and fully adaptable to your protocols.
What Digitalis is
An EDC built for the people who work in the field.
Not a generic tool. Not a spreadsheet in disguise. Digitalis was built by clinical trial experts to solve the real problems teams face.
- Web application: nothing to install, accessible anywhere
- Responsive: computer, tablet, mobile... the same experience
- Unlimited users included, at no extra cost
- Immediate deployment on your own instance
- Expert support involved in your projects
eCRF interface: patient data entry
Why Digitalis
The real problems of teams in the field.
Ill-suited tools, manual entry, laborious exports... Digitalis is built to solve them.
Ill-suited general-purpose toolsExcel, paper, unvalidated software: incompatible with regulatory requirements.
Time-consuming data entryDouble entry, manual recoding, tedious exports that eat up hundreds of hours.
Compliance that is hard to proveIncomplete audit trail, signatures that do not meet FDA requirements, insufficient traceability.
Per-user costsPer-seat licenses that skyrocket as soon as the study grows or the team changes.
Design & experience
An interface that needs no training.
Investigators, CRAs and patients use Digitalis without a manual. The design reduces data entry errors and speeds up field workflows.
Web-based, nothing to install
A browser is all you need. Chrome, Firefox, Safari, legacy-compatible. No agent to deploy on workstations.
100% responsive
The interface adapts to tablets and mobiles. Investigators enter data right at the patient's bedside.
Natively multilingual
French, English and any other language, including Chinese. Localized interface and forms.
Security & compliance
Built for the most demanding environments.
Every standard or certification is a design decision built in from the start, from the infrastructure to the audit trail.
CDISC ODM-XML
The international standard for storing and exchanging clinical data. Interoperability and quality recognized worldwide.
Interoperability21 CFR Part 11
Secure connections, complete audit trails, compliant electronic signatures. Authenticity and confidentiality guaranteed for every action.
FDA regulatoryOnemo framework
The engine behind Digitalis. Regularly audited for cybersecurity. Built for the audit trail and security requirements of health data.
InfrastructureHDS hosting
Clinical data hosted on HDS-certified servers (the French certification for health data hosting). Strict security measures required by the AFNOR certification.
Certified hostingISO 27001
Certification applicable to data hosting. An effective, robust information security management system.
IT securityGDPR & privacy
Only strictly necessary data is collected. Every user account is audited. Fully customizable legal notices.
EU compliance
Standards and certifications:
CDISC ODM
FDA 21 CFR 11
GDPR
HDS
ISO 27001
Features
Everything a clinical study requires. Nothing superfluous.
Each module answers a real need in the field, validated by quality and medical teams on pre- and post-market studies.
01
ODM Designer & multi-study eCRF
Create and edit your CRFs with ODM Designer, CDISC compliant. Deploy to the test environment in one click. Manage protocols, item groups, consistency checks and conditions.
02
Workflows & electronic signatures
Configure the read and write conditions of your forms. Define the signatory profiles and the meaning of each signature. Fully compliant with FDA 21 CFR Part 11.
03
Patient eConsent & ePRO
Electronic consent with a patient quiz, SMS validation and a mobile-first interface for ePRO entry. Patients enter their own data, without friction.
04
Dashboards & regulatory exports
Enrollment curve, open queries, adverse events: your KPIs, exportable by profile. Exports in ODM or CSV format with SAS import files.
05
Queries & audit trail
Created manually by CRAs or automatically by programmed consistency checks. A dedicated monitoring module. A complete audit trail, exportable for every action.
06
Connected devices & DataHub
Through LifeData Connect, connect your medical equipment to the Digitalis DataHub. Automatic, time-stamped collection, with no manual entry.
07
Compassionate access & site management
Investigators register through a dedicated interface. Request approval, on-the-fly site creation, automatic notifications. Suited to ATUs (French temporary use authorizations) and early access programs.
CRF Designer & study configuration
Also included
Customization
Your platform. Your rules.
Digitalis is not set in stone. Each instance is yours and 100% customizable, from the logo to custom-built business modules.
- Logo, colors and visual identity of your instance
- Access rights management by profile, site and study
- Fully configurable workflows, signatures and notifications
- Custom developments without touching the validated core
- Interfaces with CTMS, eTMF and third-party APIs
- SaMD and DTx modules, and custom business solutions
Limitless by design. Most custom developments are done without modifying the validated software core.
Testimonials
Feedback from demanding environments.
Pierre Fabre
“An ergonomic, intuitive and easy-to-use electronic tool that ensures reliable, standardized clinical data entry.”
Alqualine
“The Cerebellis team turned our needs into tools perfectly suited to our business. Attentiveness, availability, advice, deadlines met and quality follow-up were there throughout the project. Digitalis is now a reliable, intuitive and customized tool that offers excellent value for money. A collaboration we recommend without hesitation.”
Pricing
Control your budget, not your ambitions.
One Digitalis instance for your project. Monthly budget control, no commitment. All modules included, unlimited users.
Everything is included
- All Digitalis modules
- Unlimited users, at no extra cost
- No minimum term
- Configuration and adaptation included
- Expert support: almost 20 years of clinical trials
- Test environment included at no cost
Ready to launch your first study?
The Digitalis team sets up your instance in a few days. Let's talk about your protocol.