# 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. ## Connections - Regulatory standards: [[CDISC]] (CDASH/SDTM), [[MedDRA]] (adverse event coding) ## Resources - https://tentelemed.com/clinical-research/ - https://tentelemed.com/cleanweb/ (French)