Regulatory Affairs & Quality
Support for setup of a quality management system
We conduct a needs analysis for your study and help you create and manage standard operating procedures (SOPs).
Regulatory review of study documents
We give you feedback on your study documents and check them for formal aspects.
Obtaining study approval from ethics committees and regulatory authorities
We submit initial applications and amendments to Swiss ethics committees and Swissmedic on your behalf. We take care of all communication with the ethics committees and the authorities. Within the framework of our experience, we also support you in submitting your research proposal to ethics committees and authorities in other countries.
Preparation of patient information sheets
Patient information is a central document in your research project. We help you to find comprehensible and correct formulations.
Study registration and maintenance of contents in the study registers
We will help you to find out whether your study is subject to registration and, if you wish, support you with registration in the Swiss National Clinical Trials Portal (SNCTP) and/or at ClinicalTrials.gov. The DKF has an account with ClinicalTrials.gov and can open and manage access for you.
Read more about the project "Study registration at the USB".
Preparation of Annual Safety Reports
Authorities and ethics committees demand to be informed at regular intervals about safety in ongoing studies. We can provide document templates for this purpose.
Support on audits und inspections
An audit or inspection can be challenging for research groups. We have many years of experience with these processes and can therefore support you effectively.
End of the study notifications
We take over the deregistration of the study for you at ethics committees and authorities.