The company quality systems guarantee conducting clinical trials in compliance with ICH-GCP, GLP, GMP guidelines, regulatory requirements, the currently approved protocol, and applicable SOPs.
The system of standard operating procedures ensures the outstanding quality of the documentation and study conduct.
A series of activities are being performed during the whole course of the study, from start-up to completion to secure data integrity and validity:
- Protocol review
- In-process & retrospective audits
- Clinical Study Reports audits
- Regular system audits
