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Regensburg Clinical Study Center (REGCSC)

„Still research strives and wrestles, never tiring,
for the law, the reason, how and why” – Johann Wolfgang von Goethe
 
 

Our Clinical Study Center was founded on this principle.

The Regensburg Clinical Study Center (REGCSC) is an establishment of the University of Regensburg, embedded in the department of trauma surgery. It offers support in the design and organization of clinical trials in accordance with the regulations concerning pharmaceuticals and medical products (phases I through IV) concentrating mainly on clinical studies in the musculoskeletal field.

In August 2012 the Regensburg Clinical Study Center (REGCSC) was issued a certificate as a Platinum level Clinical Study Center (highest level possible) by the AO foundation, based on previous clinical trials conducted by the REGCSC.  This not only entails the participation in multi center studies, but also the initiation and management of multi center trials on an international and national level. The study center was successfully recertified in 2015.

Our clinical research specializes in the evaluation and verification of new implants in the treatment of bone-, cartilage, ligament and joint injuries. Furthermore we are actively researching new strategies to avoid and cure complications such as surgical site infections or thrombosis. The department of trauma surgery also participates in interdisciplinary research on oncological diseases (www.ukr.de/zentren/UCC/index.php).

Accurate investigations and data collection as well as the recording of all test findings are a premise to the high quality of research results not only for current patient centered care, but also considering the long term outcome. High level trials have already been conducted in the field of soccer (sport injuries, http://www.fussballmedizin.de) and multiple trauma care (http://www.epi-regensburg.de/wp/forschung/arbeitsbereich-gesundheitssystem-und-versorgung/polyqualy). 

From left to right: Head of REGCSC Prof. Michael Nerlich, Project Manager REGCSC Dr. Michael Müller, SOP Manager/Study Administrator REGCSC Gabriele Goess, Investigator/Researcher REGCSC Dr. Christian Pfeifer.
From left to right: Head of REGCSC Prof. Michael Nerlich, Project Manager REGCSC Dr. Michael Müller, SOP Manager/Study Administrator REGCSC Gabriele Goess, Investigator/Researcher REGCSC Dr. Christian Pfeifer.
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In our research center a highly qualified team of doctors, assistants and nurses, all specifically trained in the conduct of clinical trials, assist patients participating in the various trials.

All surveys are conducted in accordance to the national and international guidelines of good clinical practice, The Declaration of Helsinki, the AMG (Arzneimittelgesetz) and MPG (Medizinproduktegesetz), complying with the relevant rules and requirements for the particular trial and according to the specifications of the ethics committee (further information referring to the rules and regulations are available in the following link(http://ethikkommission.uni-regensburg.de/)

Our Study Center will be glad to provide any further information you may require. Regensburg University Medical Center

Regensburg University Medical Center
Esther Kiszler
Study Coordinator/Clinical Study Center
Department of Trauma Surgery,
Orthopaedic Surgery,
Sportsmedicine
FIFA-Medical Centre for Excellence

Tel.: ++49 (0)941/944-6769 and -6928
Fax.: ++49 (0) 941/944-876769
Email: esther.kiszler@ukr.de
http://www.ukr.de/Unfallchirurgie

 

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