Clinical Studies/Approval Procedures
Cloud-based Ecosystem
Manage and analyze patient and therapy data in single center and multicenter clinical studies and EU MDR and FDA approval procedures.
Intuitive operation and seamless integration with existing system environments. Being cloud-based the system is always up-to-date.
Conduct Studies Efficiently and Reliably
Clinical Studies and Approval Procedures
Conduct clinical studies and approval procedures with a system providing comprehensive customization for both usage scenarios.
Study Design Independent of CRO
Set up studies according to inidividual requirements – fast and efficiently without CRO.
Single Center and Multicenter Studies
The integrated site administration allows for single center and multicenter clinical studies. Each participant uses an exclusive data storage for their study data.
Multi-channel Data Collection
Collect all relevant study data from different sources using adaptive data input, data import from external information systems and data extraction from various medical devices. And save time with highly automated data acquisition.
Highly Customized Reporting
Direct and adpative reporting in web format. Real-time reporting at any stage of a study. Archiving format as an option.
Statistical Evaluations
Statistical base analyses are used to calculate distributions and variances, patterns and correlations between study parameters.
Visualizations
Visualizations of study data and results according to individual specifications.
AI-based Analytics
Complex AI-based analytics are used to compare therapies, analyze 2D and 3D image analysis and evaluate device generated data.
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