EDC solutions

 

For more than 10 years our company has collected and managed clinical data using our web-accessible, fast, robust and highly configurable proprietary EDC system. In case our customers have additional requirements to the EDC application we develop customized solutions. Our system is fully compliant with the requirements of 21 CFR Part 11 and ICH GCP.

Our eClinical solution is based on state of the art JAVA technology with an underlying ORACLE database.

Some of Key Features

User-friendly, workflow-oriented and dynamic interface
Multilingual user interface
Role based access on study documentation
Quick and easy implementation of protocol changes
Automatic generation of blank CRF and annotated CRFs (PDF)
Same user credentials for all trials
Standard and customized reporting capabilities
Convenient change of validation checks during study conduct
Customized interfaces for data upload (e.g. laboratory data)
Data exports into Comma-Separated Values (CSV) Files
Email notification for customer defined events and keywords
Training options as face-to-face, web-based or e-learning 


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