The company Orgamed System was founded in 1986 and dealt initially with conducting clinical trials according to German Drug Law (AMG) of phase IIa-IV.
By expanding the service range and spectrum, we are now specialising as a CRO in conducting and project managing of clinical trials according to Medical Device Law. In this area, we are responsible for national and international sponsors for the entire study management in all German speaking countries.
Since the formation of the company, Claudia Fuchs-Brucker has been the responsible general manager on site.
As a lawyer with an immense medical background, she proves as a competent partner for the conducting of medical studies and is a valuable link between sponsors of national and international pharmaceutical industries in the field of medical devices. Her vast experience in cooperating with Authorities and Ethic Committees enables a fast trial start and saves valuable resources.
After more than 15 years of clinical monitoring, she is now in charge of the training and advanced training of Clinical Research Assistants in the On-Site Management.
Dr. med. Rudolf Fuchs is Principal Investigator of large registration studies, Medical Director of the company and leading Principal Investigator for international clinical trials. In the CRO function of Orgamed System, he is responsible for the medical training and advanced monitor training, professional supervision of the On-Site Monitoring and the medical/scientific communication with the Sponsors. A professional and competent recommendation in scientific matters is therefore given at all times.