We conduct design and management of clinical trials of phases I-IV of commercial / non-commercial (IIT) and non-interventional studies (NIS: AWB, register studies, cohort studies, etc.):
- Setup, coordination with and for the involved parties
- Development of protocols, informed consents, trial documents
- Project management, budget planning, contract preparation
- Design and printing of case report forms (CRFs)
- Site selections
- Project specific training of clinical monitors and site staff
- Design, organization and conduct of expert meetings
- Organization of investigator meetings