Magana Trial Manager

Magana Trial Manager is a browser-based eCRF/EDC (Electronic Data Capture) software developed by MaganaMed for data collection and documentation in clinical trials and Post-Market Surveillance (PMS) activities. It is designed for clinical research teams, CROs, academic institutions, and medical device companies that need a validated, GDPR-compliant system to manage study data, participant workflows, and regulatory documentation.

The platform is built around a modular architecture, allowing study teams to select only the functionality they require. Study setup is described as achievable within approximately ten minutes, and the system operates entirely in a web browser without requiring dedicated client software.

Available Modules

• Multicenter Module: Supports participation from multiple study centers with individual access rights per center. Patients can be pseudonymized and assigned to specific centers, enabling recruitment rate tracking across sites.
• Query Management: Provides structured handling of data queries within the study system, including audit trails to support data integrity and proper documentation.
• Survey / ePRO: Allows creation and distribution of surveys that participants can complete on any device. Data is saved automatically, and each participant accesses only their own survey through secure login.
• Biosample Management: Tracks biosample workflows from label creation through shipping and lifecycle management, documenting all phases from collection to analysis.
• Visit Scheduler: Supports planning and management of study visits with controls for handling sensitive participant data in a compliant manner.
• Randomization: Assigns participants to study groups using randomization methods to support transparency and reliability in treatment allocation.
• Identity Management: Enables authorized personnel to work with participant names rather than pseudonyms in daily operations, with individual access rights controlling who can view personal data.
• API Access: Provides secure API connectivity to study data and modules, supporting workflow automation, integration with external systems, and functional extension based on study requirements.

Key Capabilities and Benefits

• Intuitive operation: The browser-based interface is designed to simplify data collection and improve overall data quality, with users reporting minimal training requirements for study site staff.
• Regulatory compliance: The system is described as fully compliant with GCP, FDA 21 CFR Part 11, HIPAA, and DSGVO/GDPR.
• Data security: Data is hosted in ISO 27001 certified data centers to protect sensitive information and maintain data integrity.
• Transparent pricing: Costs are calculated based solely on the modules selected and the duration of use, with no undisclosed fees.
• Long-term support: MaganaMed is an owner-managed company with a stated customer-oriented approach, offering direct and responsive technical support.

Reported Use Cases

• Multi-center randomized controlled trials in academic and clinical settings
• Medical device studies and Post-Market Clinical Follow-up (PMCF) registries
• Investigator-initiated and sponsored trials across different study types
• Large-scale epidemiological studies, including a reported antibody study with over 4,000 participants

Magana Trial Manager supports both free trial access and demo requests. The platform is used by clinical development teams, CROs, university hospitals, and diagnostics companies across Europe and the United States, and is positioned for studies requiring compliance with multiple international regulatory frameworks.