Discover Digitalis

An EDC thought for you

Digitalis is an innovative data collection tool (Electronic Data Capture). Digitalis provides you with all the tools you need for a pleasant and complete collection and management of quality clinical data. It is a dynamic and ergonomic web application, whose strength lies in its ease of use and ability to adapt to your specific needs.

The entire Digitalis team is at your disposal for any questions or suggestions. Contact us

Modern Design

Software focused on the user experience

The Digitalis interface is clear and intuitive. Our goal is to offer you a modern and lightweight design so you can use the software with ease.

Web and responsive

Accessible everywhere, on any device

Do you have a web browser? Perfect, you are ready.

Digitalis is a web-based software, which requires no special installation, a web browser and an internet connection are enough. The software is designed for the latest web browsers (Chrome, Firefox, Safari) but remains functional on older browsers.

Computer, tablet ... Digitalis adapts to the size of your screen.

Whether you work on your computer or on your tablet, Digitalis is used in the same way and adapts to the size of your screen. Thus, you can use the application from your tablet effortlessly using a thoughtful interface designed for your device.

Quality, Compliance and Safety

Software built on reliable bases

                  
Meets the CDISC ODM-XML standard
                  The CDISC ODM standard defines the rules for storing and exchanging clinical data. Digitalis goes further and relies entirely on this standard to manipulate clinical data, a mark of quality and interoperability of the data collected.                

Complies to FDA 21 CFR Part 11
                  Digitalis complies with the regulations of Chapter 21 CFR Part 11 of the Food and Drug Administration. The authenticity, integrity and confidentiality of the data are ensured by the application: secure connections, audit trails, electronic signatures, etc.                

Built on a robust framework: Onemo
                  Digitalis is built on a robust and powerful framework: Onemo. Very flexible and powerful, Onemo is designed to develop rich and interactive web applications. It is designed to meet Digitalis standards (audit trails, security ...) and is regularly audited for cybersecurity.

                  
Health Data Hosting
                  Clinical data are hosted on a secured Health Data Hosting server certified by the French HDS certification. This certification imposes strict security measures for the storage and management of health data.                

ISO 27001
                  ISO 27001 certification applies to data hosting and attests to the implementation of an effective and robust information security management system.                

GDPR & Data privacy
                  Digitalis complies with GDPR: only the personal data essential for the software's operation is collected, and each user account is audited. Legal notices (privacy policy, cookies, terms of use) are customizable. Digitalis uses no cookies except for the login cookie, which is essential for the platform.

Custom eCRF

Build your own eCRF to suit your needs

Fine-tune your platform with total autonomy: eCRF and form design, graphic choices (logo and colors), access controls, modules, notifications, workflows, etc.

The core business of the Digitalis team is technological innovation and the implementation of customized solutions. We are ready to implement your very specific needs within your platform (additional modules, graphics, etc ...). Most developments can be carried out without touching the validated software kernel. In a nutshell: you're never held back with Digitalis.

Features

Main features present in Digitalis

Multi-CRF

Create a new study in just one click:

It shares a common base of centers, countries and users
Accessible via a dedicated URL within your platform
Configure global study parameters: ePRO, informed consent, forms, workflows, etc., independently of other studies

CRF Design

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.

Access rights

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.

Rights management

Create countries, specify the studies concerned by these countries, create sites, assign profiles to your users.

Workflows & eSignature

Define the conditions under which a form can be read or written: signature of previous form, CRF field value, etc.

Configure which forms are subject to signature, signatory profiles and the meaning of each signature

Notifications

Schedule rich notifications, decide on:

Sending conditions
Recipients (mailing list management)
Key and contextual variables (study name, eConsent signature URL, etc.)
ontextual attachments (PDF of signed form, AE, purchase order, etc.)
Subject and body of the email with insertion of selected variables

Documents

Manage your study documents, specify:

Title
Version
Language of the document
Consultation rights: destination studies, profiles and authorized centers

Only the relevant documents are then available on your user's dashboard.

You can subsequently refer to these documents in your study: within a form, when signing an eConsent, etc.

Compassionate Use

Investigator Registration

Practitioners register via a dedicated interface, enter the study(s) of interest and information from their site. Appropriate for compassionate and early access programs.

Management of access requests

Verify and correct the information received before validating requests. Create centers on the fly if necessary, notify investigators when their request is processed.

eConsent

Write the text of the eConsent (which may refer to documents on the platform) and create a quiz for your patients.

When an eConsent is created, an e-mail is sent to the patient asking them to read the text and answer the quiz. The patient can then access the signature via SMS, with a code to be entered in the dedicated interface. This signature unlocks the possibility for the investigator to include the patient in the study.

Forms

Find your visits in an ergonomic menu and the selected form in an input space. The form can be enhanced with diagrams and instructions for investigators.

Connected devices

Using our LifeData Connect solution, add your equipment to the Digitalis Data Hub and automatically collect data from medical devices.

ePRO

Digitalis features a « mobile friendly » display, enabling your patients to enter their data themselves, effortlessly.

On login, a summary of the forms to be entered is displayed. At the end of data entry, a validation message indicates that the work is complete.

Queries

Manual submission by the CRA directly on the patient form or automatic creation via programmed consistency checks. The investigator can correct the error or explain the reason for the inconsistency. A dedicated module enables queries to be managed and supervised.

Dashboards

Inclusion curve, open centers, pending queries, adverse events, etc. Find your KPIs and all useful, exportable summaries on a dashboard adapted to each user.

We integrate on demand the supervision interfaces useful to your study: diagrams, data tables, curves, pie charts, etc.

But also ...

Multi-factor authentication
Authentication via Pro Santé Connect or Pasrel/Plage
Multi-language (French or English by default, any language can be integrated including Chinese)
Management of countries, centers, users, user profiles
Annotated CRF
DVP (export of programmed queries)
Data export, in ODM or CSV formats (with SAS import files)
Data lock (per form, patient, or global)
Audit trail with dedicated, exportable module
Data imports: codings, CSV
User activity logs and management of banned IPs
Logs of emails sent by the platform
Management of platform texts: GDPR, contact information, etc.
Test environment: for user training, or to validate any amendments to the CRF.

Prices

Flexible pricing under control

Thomas Perraudin,
CEO

Digitalis is made to evolve

Order an instance of Digitalis for your project and keep monthly control of your budget, with no obligation to commit to a specific duration, and no limit on the number of users or functionalities. You'll automatically have a complete instance with all Digitalis modules, and the ability to create new studies within your platform at lower cost. With almost 20 years' experience in clinical trials, we are ready to configure and adapt Digitalis to your study.

Thomas Perraudin
CEO

Thomas Perraudin

Ask us your questions