Quality Management

We are committed to high quality in all areas of our business.

In accordance with GCP, ICH guidelines and regulatory requirements at national and international level, we ensure that our clients are provided with the best possible services.
This is achieved by an established and continuously improved system of SOPs, by projects effectively monitored and controlled for process performance and product quality and by the conduction of systematic internal and external (investigational site and vendor) audits.
We offer auditing service assessing compliance with ICH-GCP, local requirements, Standard Operating Procedures and other internal and external standards.
Derived from the audit results we provide constructive recommendations for efficient improvement of your study conduct.

Our audit service includes Europe wide:

  • Investigational site audits
  • Inhouse audits / TMF audits
  • Vendor audits
  • Document Audits (Protocol, Patient Information / Informed Consent, Case Report Forms, Clinical Study Report)