Clinical Research

Online electronic case report form (eCRF) for studies, registries or cohorts. This is a foundation module of the solution. It is in this module (restricted version) that the clinical data will be retrieved.

Module allowing data entry by the patient directly through a dedicated secure web portal. Alerts by email and SMS

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Module allowing the generation of parameterised randomisation lists which can be used directly by the IWRS module. The Interactive Web Responsive System (IWRS) allowing the use of fully configurable online randomisation (number of arms, blinding, etc.) with the option to interface with the management of Treatment Units (TU).

This is the module for the design of eCRF. The Designer is installed on the user’s workstation. The Designer module allows data managers, project managers, clinical research assistants to fully configure the project’s electronic case report forms (eCRFs) as well as the many automatic input controls, and to manage any changes (particularly for registries) that may occur during the course of a project.

Module providing access to the WEB version of CleanWeb (accessible from an internet browser) to a project management portal, collaborative tool for project monitoring, user forum, etc

Combined with the IWRS/IVRS, this module allows the management of stocks of therapeutic units as well as their supply in a way that enables more efficient use of resources

Specific dashboards allow the configuration of a selection of specific variables for which the user wishes to display data.
• New rights to finely control access to dashboards
• Data display format: several lines per patient
• Set up a default request for each each user profile that has access to the dashboard

The eCalendar module allows the configuration of the workflow of patient’s visits according to the clinical protocol and the calculation and updating of the provisional calendar for these visits, as well as comparison with the calendar of its effective implementation.
This module facilitates the monitoring of each patient’s progress in the study, reduces the risks of deviation (through a system of reminders/alerts) and detects possible deviations from the schedule of patient visits. It also enables the organisation of monitoring, and particularly on-site monitoring (“Monitoring” module) of the patient. Last, but not least, the Calendar module enables control access to the patient self-questionnaires (“ePRO” module).
Coupled with the eCalendar, the shared agenda enables the different actors in clinical research to manage human resources, time spent on each project or tasks identified as important for the follow-up teams

This module enables interoperability with other ISs, thanks to functional APIs that allow this interconnection

This module generates fees note, hospital costs, and project management coupling

This module allows monitoring visits to be performed remotely, integrating:
• Modification of the visit planning interface
• Integration with shared calendar
• Integration with teleconsultation software (API)
• Access control with workstation recognition
• Audit trail
• Detailed study and design

The Clinical Trial Management System (CTMS) module provides the administrative management of a study, the centres and their users, etc… and the monitoring management and follow-up. 
The “Study Group” part allows for the classification of studies and the calculation of statistics and corresponding dashboards according to specific groups, as well as statistics available according to these groups. The “Study Group” part allows for the classification of studies and the calculation of statistics and corresponding dashboards according to specific groups, as well as statistics available according to these groups.

The electronic Trial Master File (eTMF) allows the sponsor to organize the archiving of study documents in compliance with current regulations. The eTMF module supports the maintenance of a repository of all types of documents that can be collected during a study. This repository is based on the CDISC Trial Master File Reference Model and is available for download
 • The configuration, for each study, of the types of documents to be collected and the generation of the list of expected documents The eTMF module allows:
• The maintenance of a repository of all types of documents that can be collected during the study. This repository is based on the model established by the Drug Information Association (DIA) and is available for downloadable
• The configuration, for each study, of the types of document to be collected and the generation of the list of expected documents.

Our intuitive electronic consent (eConsent) solution facilitates participation of patients in clinical trials, seamlessly and efficiently. Thanks to a close link between eConsent and our CleanWeb global e-Platform, interactions between patients, professionals and healthcare organisations are streamlined.

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Our Safety reporting module allows for Pharmacovigilance Data Management / in conjunction with the Safety Easy platform. Our robots can also be adapted to other market platforms with specific IT development.

The CleanWeb Medical Imaging module streamlines the overall management of imaging in clinical trials.
Integrated with EDC, this module enables to upload files directly from the web browser and from the eCRF interface. It associates variables from the eCRF as descriptive metadata. Both DICOM & NON-DICOM files can be uploaded.
This module includes data anonymisation through automatic or semi-automatic anonymisation techniques and deletion of all patient identification data. It is delivered with a DICOM and video viewer. Integrated with EDC, this module enables to upload files directly from the web browser and from the eCRF interface. It associates variables from the eCRF as descriptive metadata. Both DICOM & NON-DICOM diles can be uploaded.
This modules includes data anonymisation through automatic or semi-automatic anonymisation techniques and deletion of all patient identification data. It’s delivered with a DICOM and video viewer.

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