Our independent Quality Assurance Unit cares for all trial-related aspects. From a systematic point of view, they supervise our training procedures and staff qualification, SOP development and maintenance, SOP application and compliance, and they accompany our Quality Management System by internal system audits.
[sba]»A part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000 definition)«[/sba]
Our QA team monitors our subcontractors – systematically and repeatedly.
And – retrospectively, our auditors control adequate performance in study-related audits – their audit certificate becomes an integral part of the study report.
From the site selection / subcontractor qualification visit of your QA to your study audits – our highly experienced QA team is your competent partner for all your questions, for adequate support and, of course, for comprehensive clearing of CAPAs.
Our auditor team is experienced in all types of inspections – European, FDA and ANVISA. Continuous updating on the latest trends of authorities’ inspections is essential. Thus, we care for external training, knowledge management and regular exchange with other experienced QAs.
You need QA support? Maybe you are planning to improve your own GCP quality management system? Or are you planning subcontractor qualifications / study audits and you are lacking adequate capacity? We may have the solution for you:
»A part of quality management focused on providing confidence that quality requirements will be fulfilled (ISO 9000 definition)«