To ensure that the trial documentation is present, complete and in compliance with ICH-GCP, local regulations and study protocol.

  • Monitoring plan design
  • Providing and monitoring the communication plan (reports)
  • Preparation and execution of Site Initiation Visits (SIVs), Monitoring Visits (MOVs), Close-Out Visits (COVs)
  • Report of SIVs, MOVs, and COVs
  • Safety monitoring
  • Procedures to assure a uniform monitoring
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