Company History

Orgamed System was founded in 1986 and began its activities in the pharmaceutical sector by conducting clinical trials according to the German Medicines Act (AMG) in phases IIa through IV.

Over the years, the range of study indications expanded across various medical fields, including cardiology, angiology, neurology, pulmonology, diabetes, renal insufficiency, oncology, orthopedics, and wound therapy.

In the 1990, the scope of activities was extended with two further areas, the Project Management for clinical trials and consulting services in medical and medico-legal areas.

Since 2000, the range of services has been expanded to include clinical monitoring, study consulting, and CRA activities for research-oriented pharmaceutical companies – initially in the DACH region (Germany, Austria, Switzerland), and later internationally. 

From 2009 onwards, Orgamed System also began collaborations with international medical device manufacturers and sponsors.
In the same year, the company extended its activities to include Regulatory Affairs Service.
Since then, Orgamed System has increasingly specialized as a CRO (Contract Research Organization) for Medical Device studies – today primarily in accordance with the EU MDR 2017/745 and national regulations in Europe, Switzerland, and the United Kingdom. We support and collaborate alike, with large medical device manufacturers and start-up companies from the very beginning – from consulting and approval processes to conducting and managing clinical studies, both pre- and post-market approval.
For national and international sponsors, we manage the complete study process in Germany and throughout the European Union.
Over the past 10 years, our range of services has further expanded up to date, with compassionate use approval processing, clinical field services and medical writing.

Claudia Fuchs-Brucker is the founder and Managing Director (CEO) of Orgamed System. As a lawyer with in-depth medical expertise, decades of experience in study conduct and study management, as well as over 30 years of experience in clinical monitoring including leadership, she is a highly competent and valued partner for many national and international pharmaceutical and medical device companies and sponsors.

Dr. Rudolf Fuchs, formerly and from the start of the company, the Medical Director of Orgamed is today our medical and scientific advisor.  With his own study center, he has been active as a lead principal investigator in international studies for decades, and participated in the conduct of many large-scale clinical trials. In the field of CRO activities, we greatly appreciate being able to rely on his competent professional advice on scientific questions, SAE evaluations, and  prior to study submissions.