CleanWeb

CleanWeb, developed by Telemedicine Technologies, is a secure internet platform dedicated to the electronic management of clinical trials and registries. It is designed for sponsors, study coordinators, physicians, and patients involved in clinical research, and supports studies of any phase, size, and complexity. The platform is available either as a SaaS subscription or through a project-based approach, allowing organisations to select only the modules and services they require.

The solution covers a broad range of clinical data management functions, including eCRF, ePRO/eCOA, eConsent, IWRS, IMP management, vigilance, medical imaging, eTMF, CTMS, and remote source data verification (rSDV). It is deployed across more than 64 countries, with over 20,000 investigational centres, more than 3 million patients in its database, and over 50,000 users worldwide.

Basic Modules

• eCRF: The foundation module of the platform, providing an online electronic case report form for studies, registries, and cohorts. Clinical data is captured and retrieved within this module.
• ePRO (Web or SMS): Allows patients to enter data directly through a dedicated secure web portal, with alert notifications sent by email and SMS.
• Randomisation / IWRS: Generates parameterised randomisation lists and supports a fully configurable Interactive Web Responsive System (IWRS) for online randomisation, including configuration of number of arms, blinding options, and optional interfacing with Treatment Unit management.
• Designer: A workstation-installed module that allows data managers, project managers, and clinical research assistants to configure eCRF forms, set up automatic input controls, and manage changes throughout the course of a project, including for registries.
• Directories & Administration: Provides web-based access to CleanWeb via an internet browser, including a project management portal, collaborative monitoring tools, and a user forum.

Optional Extension Modules

• Trial Supply Management: Combined with IWRS/IVRS, this module manages stocks of therapeutic units and their supply to support more efficient resource use.
• KPI, Charts & Export: Provides configurable dashboards for selecting and displaying specific variables, with fine-grained access controls, multiple data display formats, and the ability to set default queries per user profile.
• eCalendar & Shared Agenda: Configures patient visit workflows according to the clinical protocol, calculates and updates provisional visit calendars, compares planned versus actual visit schedules, and sends reminders and alerts to reduce protocol deviations. The shared agenda supports human resource management and time tracking across projects and tasks. This module also integrates with the ePRO module to control access to patient self-questionnaires.
• Interoperability: Enables interconnection with other information systems through functional APIs.

Add-on Modules

• Fees Management: Generates fees notes, hospital costs, and project management coupling.
• Remote Monitoring: Supports remote monitoring visits, including modification of visit planning interfaces, integration with the shared calendar, integration with teleconsultation software via API, access control with workstation recognition, audit trail functionality, and detailed study and design review.
• CTMS (Clinical Trial Management System): Provides administrative management of studies, centres, and users, as well as monitoring management and follow-up. Includes a Study Group feature for classifying studies, calculating statistics, and generating dashboards by group.
• eTMF & eISF (Electronic Trial Master File): Allows sponsors to organise and archive study documents in compliance with current regulations. Maintains a repository of all document types collected during a study, based on the CDISC Trial Master File Reference Model and the Drug Information Association (DIA) model. Supports per-study configuration of document types and generation of expected document lists.
• eConsent: An electronic consent module that facilitates patient participation in clinical trials. It is closely integrated with the CleanWeb platform to support interactions between patients, healthcare professionals, and organisations.
• Safety Reporting: Supports pharmacovigilance data management in conjunction with the Safety Easy platform. Robots can be adapted to other market platforms through specific IT development.
• Medical Imaging: Manages imaging within clinical trials, integrated with the EDC system. Supports direct file upload from a web browser and from within the eCRF interface, associates eCRF variables as descriptive metadata, and accepts both DICOM and non-DICOM files. Includes automatic and semi-automatic data anonymisation with deletion of patient identification data, and is delivered with a DICOM and video viewer.

Deployment Options

• SaaS mode: Suited to organisations that design multiple clinical trials per year. Includes a Qualiopi-certified training course enabling users to configure trials independently, from simple to complex.
• Project-based approach: Suited to organisations that design clinical trials occasionally. Allows clients to either configure their own e-Platform using CleanWeb or rely on Telemedicine Technologies' data management team to set up tailored platforms. No long-term commitment is required under this option.

CleanWeb is compliant with current data management regulations for clinical research. The eTMF module references both the CDISC and DIA document models, and the platform supports regulatory-grade audit trails and access controls across its modules.