Clinical Trial Monitoring

Our Clinical Trial experts are the backbone of every trial and manages all activities coordinated thorough study team meetings and communications, including study start-up activities, maintenance to study close-outs by utilizing our proprietary CTMS to report up-to-date study status, patient enrollment, site information and deadline and milestone tracking for regulatory documents and submissions.

CRAs will manage site visit objectives, including:

  • Full SOPs (Standard Operating Procedures)
  • Study & site startup activities
  • Documents and Submissions
  • IRB/EC meeting activity
  • Contracts & budgets
  • Screening and enrollment
  • Study subject activity throughout the trial
  • Regulatory documents (electronic and hard-copy)
  • Monitoring visit Reports, calendars and schedules
  • Safety Reporting
  • Ensuring signed informed consent forms
  • Source Data Verification (SDV), based on the protocol and study plans
  • Reviewing all eCRF/CRFs and discuss trends with site staff
  • Evaluating eCRF/CRFs for serious adverse events
  • Performing drug accountability
  • Reviewing investigator study files for completeness
  • Ensuring protocol compliance
  • Encouraging and supporting sites