Quality data and compliance with GCP regulations is our core philosophy. We achieve this goal by ongoing in-depth training of our clinical team on internal standards and external regulations. Our Quality Management personnel combines extensive experience in the pharmaceutical and CRO industry with profound knowledge of ICH-GCP, CFR and local regulations. With internal study and system auditing we ensure compliance with standards and continuous improvement of our processes. Essential part of our QM system is our risk-based approach on computer systems validation according to the GAMP4 standard.

Scope International has been inspected by the US FDA in 2008 and by the German BfArM (EMEA inspection scheme) in 2006. We are regularly audited by major pharmaceutical companies and are audited member of the Bundesverband Medizinischer Auftragsinstitute (BVMA).

Bioanalytical Quality

Our analytical laboratory complies with GLP regulations which was certified most recently in 2007. This standard includes regular auditing by an independent quality assurance unit, ongoing training of personnel, validated computer systems and high documentation standards. Analytical methods are validated according to international standards prior to routine analysis and all of our analytical protocols and reports are audited.