In every study, the safety of study participants has highest priority. Before the study can begin, the project has to be approved by the regulatory body. Depending on the investigational drug/device, either the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Bonn or the Paul-Ehrlich-Institut (PEI) in Langen is responsible. Both institutions report to the Federal Ministry of Health (Bundesministerium für Gesundheit). Furthermore, before a study starts, an independent ethic commission must weigh up all the potential risks against the benefits for the participants. Members of the ethic commission come from different professions (physicians, natural and legal scientists, philosophes and theologians). They discuss every study in detail. Only if these independent review boards come to a positive result, without any complaints can the study be conducted.

All studies running at KliFOs are reviewed and approved by the regulatory and by the ethic commission Lower Saxony (Ethikkommission Niedersachsen).

We are subject to monitoring obligation by the regulatory authorities (State Labour Inspectorate Oldenburg). GCP control inspection by the regulatory authorities (State Labour Inspectorate Oldenburg) on 31.08.2015 and 01.09.2015.

Result: No critical and no serious findings, only minor ones. Excerpt from the inspection report: "The site KliFOs in Osnabrück is due to its facilities and staffing suitable to conduct clinical trials with drugs. In particular, the good organizational structure resulted in a high GCP-compliance and a small number of deviations. The great commitment of the Managing Director and the employees is worth emphasizing."