Medigen Suite

Medigen Suite is an integrated eClinical platform designed for sponsors and research teams running complex global clinical trials. It combines electronic data capture, medical imaging, patient engagement applications, and centralized trial management into a single modular ecosystem, with the stated goal of supporting trial execution and regulatory submissions to agencies including the FDA, EMA, NMPA, and PMDA.

The platform is organized around three core products — Maptrial® CTMS+, Catchtrial® EDC+, and Catchtrial® Apps+ — each addressing a distinct area of trial operations. These products can be used individually or combined into a unified digital environment tailored to the requirements of a specific study.

Maptrial® CTMS+ — Trial Operations and Governance

• Functions as a digital trial governance and oversight platform.
• Provides real-time visibility and accountability across global trial operations.
• Supports regulatory traceability for complex multi-site studies.
• Includes a clinical trial management system (CTMS) and electronic Trial Master File (eTMF) capabilities.
• Covers site payments, risk-based monitoring, and site training modules.

Catchtrial® EDC+ — Clinical Data Capture and Analytics

• Serves as a digital trial execution system integrating data capture, medical imaging, and AI-driven analytics.
• Supports DICOM imaging management within the same platform as EDC.
• Includes randomization, MedDRA coding, and safety adjudication functionality.
• Designed to support site-wide inspection readiness.
• Incorporates analytics and AI tools to support data-driven decision-making during trial execution.
• Includes product tracking capabilities.

Catchtrial® Apps+ — Patient and Site Engagement

• Provides applications targeting patients, clinicians, and study teams.
• Supports electronic Patient-Reported Outcomes (ePRO), electronic Clinical Outcome Assessments (eCOA), and electronic informed consent (eConsent).
• Converts collected patient data into outcomes intelligence for study teams.

Modular Platform Capabilities

• Features across Catchtrial® EDC+ and Maptrial® CTMS+ can be selected and combined into a single flexible ecosystem.
• Available modules include: EDC, DICOM imaging, randomization, safety adjudication, site payments, MedDRA coding, site training, analytics/AI, product tracking, risk-based monitoring, ePRO, eCOA, eConsent, CTMS, and eTMF.
• The modular structure allows configuration based on the specific needs of an individual clinical study.

Medigen Suite is developed under Meditrial Europe Ltd. and supports regulatory submissions to the FDA, EMA, NMPA, and PMDA. A live demo is available, and the platform can be reached through direct contact channels for product inquiries.