Fastrial

Medigen Suite, operated by Meditrial Europe Ltd., develops an integrated eClinical platform designed to support the execution and regulatory submission of global clinical trials. The platform combines electronic data capture, medical imaging, patient engagement applications, and centralized trial management within a single ecosystem, serving sponsors, sites, and study teams across complex multi-regional studies.

The suite is built to produce approval-ready clinical evidence for regulatory submissions to major agencies including the FDA, EMA, NMPA, and PMDA. Its modular architecture allows organizations to select and combine specific features to match the requirements of individual trials.

Core Products

• Maptrial® CTMS+ – A digital trial governance and oversight platform providing real-time visibility, accountability, and regulatory traceability across complex global trials. It is described as a trial operations intelligence solution.
• Catchtrial® EDC+ – A digital trial execution system that integrates data capture, medical imaging, and AI analytics. It is designed to support global operational efficiency and site-level inspection readiness.
• Catchtrial® Apps+ – A patient and site engagement application suite covering ePRO, eConsent, and eCOA functionality, with the aim of converting collected outcomes data into actionable intelligence for patients, clinicians, and study teams.

Modular Capabilities

• Electronic Data Capture (EDC)
• DICOM medical imaging
• Randomization
• Safety adjudication
• Site payments
• MedDRA coding
• Site training
• Analytics and AI
• Product tracking
• Risk-based monitoring
• ePRO, eCOA, and eConsent
• Clinical Trial Management System (CTMS)
• Electronic Trial Master File (eTMF)

Platform and Compliance Details

• The platform is positioned for global trial execution, with regulatory traceability built into its governance and data management workflows.
• Submissions support spans multiple major regulatory jurisdictions: FDA (United States), EMA (Europe), NMPA (China), and PMDA (Japan).
• The suite has been available since at least 2009, based on the company's stated operational history.
• Medigen Suite is offered with a live demo option, and the platform can be configured in a modular fashion to fit the specific needs of a given clinical study.

Medigen Suite is accessible via its web platform and can be reached through its sales and support contact channels for organizations seeking to evaluate or deploy the system for clinical research programs.