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Clinical trials

Monitoring (Europe-wide)

Pre-study monitoring

  • Recruitment of study sites
  • Verification of site qualification
  • Conducting of pre-study visits
  • Preparation and contracting of fee agreements
  • Planning, development and packing of trial supplies
  • Development of monitoring guidelines
  • Project-specific training of clinical monitors
  • Site initiation

Periodic monitoring

  • On site monitoring
  • Inhouse monitoring / remote monitoring (eCRF)
  • Co-monitoring
  • Patient tracking
  • Reimbursement of investigators
  • Administration of expense allowance for patients
  • Planning, organization and performance of investigator meetings
  • Administration of Trial Master File
  • Drug accountability
  • Site support between monitoring visits
  • Site closure