As part of clinical data management (CDM), the parameters defined in the study protocol are transferred in an appropriate form for data collection, the Case Report Form (CRF) or electronically as an eCRF. Since the validity of any statistical analysis depends on the quality of the underlying raw data, this data has to meet exacting standards.

We use secuTrial as the EDC (Electronic Data Capture) system. This is a web-based, high-performance study software solution that enables the fully internet-based capture and management of patient data in clinical (multi-center) studies whilst fully satisfying all approval and privacy-related requirements as well as complying with the highest quality standards. secuTrial meets all regulatory standards (CRF, GCP) and features all FDA-compliant functions such as audit trail, roles and rights concept and electronic signature. At the same time, secuTrial has also undergone multiple independent benchmarking audits and is certified as fully compliant with 21 CFR Part 11 and the regulations based thereon.

To apply for a consultation on clinical data management for biometric or data-related matters, please use our consultation form.

Consultation form

Should you have any questions, feel free to contact the responsible member of staff in our Institute:

Sebastian Baecke

E-mail: 

Phone: 0391-67 13546