Study-preparation:

  • planning of clinical studies
  • preparation of protocol
  • design of Case Report Form
  • evaluation and selection of sites/investigators
  • clinical trial authorisation, notification to health authorities
  • preparations for obtaining ethics committee approvals
  • organisation and conduct of investigators meetings and training

Study-conduct:

  • project management
  • monitoring on site/in house (all phases)
  • management of post-marketing surveillance projects
  • handling of serious adverse events
  • monthly status report
  • integrated medical-statistical reports according to international guidelines (e.g. ICH)
  • medical writing (e.g. publications, expert reports)