Monitoring

Our staff has a thorough knowledge of local regulations and ‘good clinical practice’ (GCP) processes. We adapt easily to our customers’ needs. We are totally flexible and can follow your procedures or you can ask us to employ our own – it’s up to you.

We can assist you with:

  • Phases I to IV (in Australia or globally)
  • Site feasibility and identification
  • ‘Investigator’ and ‘monitor’ meeting preparation and set-up
  • All types of monitoring visits including site selection, Initiation, routine and study-closure visits
  • Local regulatory submissions
  • Obtaining local HREC/EC/IRB approvals
  • Site management
  • Good clinical practice (GCP) training
  • Monitoring, communication and study-plan generation and implementation
  • Query resolution
  • Blinded and unblinded investigational
  • Product accountability
  • Subject recruitment plans and implementation.