MaganaMed

MaganaMed is a software company based in Regensburg, Germany, that has been developing eCRF and EDC (Electronic Data Capture) software for clinical studies since its founding in 2017. Its primary product, the Magana Trial Manager, is a browser-based platform designed for data collection and documentation in clinical trials and Post-Market Surveillance (PMCF) activities. The company serves a range of customers including academic research institutions, contract research organizations (CROs), medical device companies, and hospital-based research teams across Europe and the United States.

MaganaMed operates as an owner-managed company with three managing directors — Dr. Philipp Pagel, Dr. Torsten Winkler, and Jakob Niggel — and describes its corporate philosophy around three values: communication, digitalization, and customer orientation. The company emphasizes long-term partnerships with customers and positions its software as a tool that integrates smoothly into existing clinical workflows without adding operational complexity.

Magana Trial Manager — Modules and Features

• Multicenter Module: Allows multiple study centers to participate in a single study with individual access rights. Supports patient pseudonymization and assignment to centers for tracking recruitment rates.
• Query Management: Provides structured handling of data queries within the study system, including audit trails to support data integrity and proper documentation.
• Survey / ePRO: Enables creation and distribution of surveys that participants can complete on any device. Features automatic saving and secure, individual participant access to their own data.
• Biosample Management: Covers biosample workflows from label creation through shipping and lifecycle tracking, documenting all phases from collection to analysis.
• Visit Scheduler: Supports planning and management of study visits with a focus on compliant handling of sensitive participant data.
• Randomization: Assigns study participants to treatment groups using randomization methods to support transparency and reliability in treatment allocation.
• Identity Management: Allows authorized personnel to work with participant names rather than pseudonyms in daily operations, with secure storage and individual access rights.
• API Access: Provides secure API access to study data and modules, enabling workflow automation, integration with external systems, and functional extension based on study requirements.

Core Capabilities and Platform Characteristics

• Browser-based software designed for intuitive operation, with the goal of simplifying data collection and improving data quality.
• Study setup described as achievable in approximately 10 minutes, with a modular structure allowing customers to select only the functionalities they require.
• Pricing is calculated based on the specific modules selected and the duration of use, with no undisclosed cost components.
• Supports both investigator-initiated trials and sponsored trials, as well as PMCF registries and large-scale epidemiological studies.

Compliance and Data Security

• Full compliance with GCP (Good Clinical Practice) guidelines.
• Compliant with FDA 21 CFR Part 11 requirements for electronic records and signatures.
• Compliant with HIPAA and GDPR (DSGVO) data protection regulations.
• Data is hosted in ISO 27001 certified data centers to protect sensitive information and ensure data integrity.

Customers and Use Cases

• Teleon Surgical GmbH has used MaganaMed for PMCF registry management, citing ease of eCRF form design and responsive technical support.
• FIDAM (Forschungsinstitut Diabetes-Akademie, Germany) uses the platform for multi-center randomized controlled trials, highlighting ease of use for study staff and management.
• Applied Ingenuity Diagnostics LLC (USA) uses the system for both investigator-initiated and sponsored trials, noting flexibility across different trial types.
• numares AG uses Magana Trial Manager for clinical development studies including US-based sites, having previously used other EDC systems.
• University Hospital Regensburg used the platform for a large-scale COVID-19 antibody study in Tirschenreuth involving over 4,000 participants.
• medXTeam CRO (Germany) uses MaganaMed for medical device studies, PMCF activities, and registries.

MaganaMed offers a free trial and demo option for prospective customers, and positions itself as a long-term software partner for organizations conducting clinical research, with an emphasis on direct communication and customer-specific support.