CTU Bern

Regulatory Affairs and General Consulting

Legal and regulatory requirements for clinical research projects are extensive and complex. This can be challenging when preparing and conducting research projects. We advise on questions regarding

  • the study protocol and other study documents e.g. participant information and consent form,
  • regulatory requirements especially for clinical trials with pharmaceutical products or medical devices such as categorization, applicable standards and processes etc.
  • submission to competent authority such as ethics committees and Swissmedic
  • registration
  • re-/further use of data and related data protection aspects