Competence in
Clinical Research

Clinical Trial Unit of the University Medical Center Göttingen

The Clinical Trial Unit of the University Medical Center Göttingen (UMG CTU) is based on existing organizations reaching to the year 2002. Since 2018, it is a competent partner in planning and conducting clinical studies.

 

Range of Services

The UMG CTU provides the full range of services required for clinical studies at a university medical center. In addition to assistance to prepare funding applications and to design a clinical study, the UMG-CTU tasks include project management, monitoring, pharmacovigilance, GCP-training and study nursing. A close collaboration with the Institute of Medical Statistics of UMG enables a study-specific conception of data management and biometrical solutions.

The UMG CTU On-Site-Management is responsible to assist in conduct of all studies performed at a specific UMG clinic or institute. The main goal is to establish overarching standardized processes which may lead to an efficient assignment of resources. To reflect different structural conditions, this concept is based on different modules, which might be applicable for certain clinics. Besides of an increase in overall study number, this leads to the establishment of high-quality and consistent standards.

To reflect the growing regulatory and ethical demands, UMG CTU is offering a range of training course for investigators and personnel participating in clinical studies. These courses cover the whole ranges of trainings required by ethics committees and are certified by the respective medical council of lower-saxony. In addition, further courses which aim at improving study quality are provided, in close collaboration with On-Site-Management.

The  UMG  CTU  is  cooperating  with  a  growing  range  of  national  and  international  scie ntific  organizations,  such  as  the  German  Centre  for  Cardiovascular  Research  (DZHK), the German Center for Neurodegenerative Diseases (DZNE), and the Heart and Brain Center Göttingen (HBCG). The Göttingen CCC, in close cooperation with the CCC of the Medizinische Hochschule Hannover, was jointly established as the Comprehensive Cancer Center Lower Saxony as a top oncological center of the Deutsche Krebshilfe at the beginning of 2021. Moreover, the UMG CTU is a consulting center for the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery.