Quality assurance

We are able to comply with high scientific standards for quality by ensuring our study personnel have specific competencies and receive regular training. Our staff is familiar with the correct implementation of the ICH-GCP guidelines and SOP methods, the provisions of the German Medicinal Products Act, the Ethics Commissions, data protection and compliance with professional duty of confidentiality as well as oversight by the responsible authorities and audits. These conditions contribute to ensuring drug safety and the safety of the patients throughout a study.

The quality of our test centre has repeatedly been demonstrated in numerous audits by our customers as well as through routine inspections by the Darmstadt Regional Council.

Study updates and mutual comparisons of data with the physicians providing concomitant care or with colleagues in clinical setting via fax communication, etc., fosters better control of data quality. At the same time, this approach provides an additional promotional effect for the research-based pharmaceutical company.

Regular training (e.g. GCP training with certification) of investigators, study coordinators and study nurses in technical, methodological and legal aspects are also a core part of our system.