Clinical Study Center

Prof. Dr. Martin Heni

Head of Facility

Dr. Louise Fritsche

Deputy Head of Facility

Clinical Study Center

  • The clinical study center manages all clinical studies of the IDM according to the regulations of the German pharmaceutical law (Arzneimittelgesetz-AMG) and Medical Associations Professional Code of Conduct (Berufsordnung, BO). Due to our longstanding experience, the Clinical Study Center team supports the principal investigators in the planning phase of the study with writing and handling of the study protocols to the relevant authorities; we maintain all required study documents in accordance with ICH-GCP regulations and we are responsible for successful study conduct from recruitment and enrollment of participants, to data and sample collection, documentation in electronic databases and data clearing procedures.
  • We are certified according to DIN EN ISO 9001: 2015 and continuous qualification measures for all staff members are implemented. We operate the DZD PLIS biobank and all biological samples from the studies.

 

Clinical Study Center

Link to Newsletter of the Clinical Study Center