Project Management

We find out together to what extent we can support the conduct of your clinical trial.

Please find here below and by clicking on tile “Monitoring & Site Management” our service portfolio.

  • Support in clinical investigational plan (CIP)/protocol development
  • Site selection
  • Support clinical trial agreement (site agreement)
  • Development patient informed consent form and patient information
  • Submission to ethical committees and competent authorities including preparation and follow-up as well as the corresponding interaction with the trial sites
  • Statistical Analysis Plan (SAP) and Data Management Plan (DMP)
  • Sample size calculation, data management, statistical data analysis
  • Development case report forms
  • Mediation of laboratory services and medical specialist consulting services
  • Development study manuals (e.g. monitoring plan)
  • Creation and maintenance of the Trial Master File
  • Support in the preparation of interim and final reports
  • Communication with insurance companies (e.g. patient insurance)
  • Registration of the study in public registers
  • Organization of investigator meeting

Are you missing a service you require additionally?

Please contact us