Quality and Compliance
Trust is good…
In view of the ever-increasing regulatory requirements, we are committed to excellence in quality. The integration of quality assurance and process optimization in our daily routine is a matter of course for us. In order to meet and maintain our high standards in quality we are routinely audited and certified.
Quality Assurance and Quality Control
… Control is better.
In our company, the planning, conduct, and analysis of clinical trials are performed in accordance with current national and international laws and regulations.
The validity of our quality assurance process is subject to constant reviews. If necessary, corrective measures will be implemented in our continuous optimization process. This enables us to provide the intended quality standard in a reproducible manner at any time.
Measures of internal quality assurance:
- Implementation of legal requirements in corporate SOPs
- Continuing process optimization as part of SOP management
- Systematic training and education of our employees (co-monitoring, “on-the-job” training) and study-specific training
- Independent examination of study documents in the course of the development and completion phases (e.g., clinical study protocols, CRF, clinical study reports)
- Internal audits during the entire study process (e.g., project audits, document audits, on-site audits)
- Generation of study-specific guidelines (e.g., monitoring manual)
Measures of external quality assurance:
- At your request, an external service provider can be audited (e.g., central or local study laboratory)