The purpose of Monitoring a Clinical Trial, is to verify that the participant’s rights are protected, verify the reported dates are adequate, complete, verifiable in documents sources to verify the leading of the clinical trial is in compliance with the protocol approved, with the ICH/GCP and with the existing regulatory requirements.

Our Monitoring activities consist in:

  • Making Monitoring plans
  • Evaluation of the pre‐center studio and advising the researchers.
  • Initiation visits of intern monitoring and completion
  • Monitoring reports on time
  • Security information reports
  • Handling trial documentation