Upon request we take over the entire communication with the authorities in charge as well as the ethic commissions.

Here, we pay great attention to adhere to all required rules, legal regulations and guidelines. We compile the documents that must be submitted and settle all regulatory tasks. In detail we cover the following subservices:

  • Compiling of all necessary documents to submit to authorities and ethics commissions
  • Checking of existing documents regarding adherence to legal and/or regulatory provisions
  • Registering of case series with the authorities and ethics commissions
  • De-registering of the study with the authorities and ethics commissions
  • Entry of study results in databases
regulatory affairs study