Clinical Trial Management System

Our all-in-one solution, »DTM,« provides a GCP-compliant study management system specifically designed for CROs, digital health application providers (DiGAs), medical device manufacturers, as well as hospitals and research institutes.

The Digital Trial Manager »DTM« is fully customizable and enables effective cross-site networking, making it ideal for multicenter and decentralized clinical trials (DCTs) as well as completely digital studies.

Participation in clinical trials has never been easier or more secure, thanks to our innovative web-based EDC system. Data can be collected directly from patients through an app, ensuring full compliance with GDPR. Additionally, there is the option to integrate various wearables or sensors according to specific use cases, along with a patient app designed to capture Patient Reported Outcomes Measures (PROMs).

• Simple Study Setup and Data Management: Paperless data collection and centralized management of patient and study data.
• Flexible: Accommodates any study protocol and seamlessly integrates wearables, sensors, and electronic Patient Reported Outcomes (ePROs).
• Decentralized and Digital: Seamless collaboration and cross-site management among all study participants and their respective roles.
• Comprehensive Data Oversight: Streamlined, user-friendly interface featuring intuitive dashboards and monitoring tools.
• Secure Communication: Appointment scheduling, integrated video calls, and automated notifications for enhanced coordination.
• Highest Data Security: Offered as a Docker container within your IT infrastructure or in the cloud at ISO 27001-certified data centers in Germany.
• Customizable and Tailored: Agile development and extensive support provide exceptional flexibility in configuration.
• Stronger Together: Access to a vast network of Fraunhofer expertise, academic institutions, and clinical partners.

• Dashboard with real-time reporting on study progress
• Scheduling feature for seamless planning and organization of visits
• Intuitive capture of queries and adverse events
• Secure audit trails for data entry, output, and modifications
• Effortless monitoring and analysis of all study data, with reporting and export functions available for individual patients
• Collection of patient data via eCRFs
• Capabilities for randomization and pseudonymization
• eConsent facilitated through video tools and digital signatures
• Compliance with modern authentication standards
• Data storage in HL7^® FHIR^® format
• Optional support for multiple languages