CleanWEB
Overview
CleanWEB is a French electronic clinical trial management platform developed by Telemedicine Technologies (Boulogne-Billancourt). It provides a modular, GDPR-compliant suite for the electronic management of clinical studies and patient registries. Since 2003, AP-HP has contracted with Telemedicine Technologies for institutional use of CleanWEB as the standard eCRF platform for its clinical trials.
Key Modules
- eCRF (electronic Case Report Form) is the core module supporting CDASH/CDISC compliance.
- CTMS (Clinical Trial Management System) is a project monitoring portal.
- eTMF is the electronic Trial Master File.
- eConsent handles electronic informed consent.
- Medical Imaging supports DICOM and non-DICOM upload, anonymisation, and viewer functionality integrated with the eCRF.
- IWRS/RTSM is the Interactive Web/Voice Response System for randomisation and trial supply management.
- Vigilance covers pharmacovigilance and adverse event reporting.
- Managed Access Programmes (MAP) tracks compassionate use.
- CT-SCOUT is an AI-assisted patient pre-screening and trial matching module.
Standards and Interoperability
CleanWEB supports CDISC CDASH/SDTM compliance with direct SAS export for regulatory submissions. HL7 FHIR integration is in development. Hosting options include HDS (Hébergement de Données de Santé) certified infrastructure and on-premise deployment, both GDPR-compliant.