Monitoring

The development and monitoring process of each study shows different needs on it, and at CRU-GLOBAL we have an enough flexible structure to adapt our procedures according to them, maintaining the quality of the whole process untouched.

Our monitors (CRAs) conduct:

  • Conducting site initiation visits (SIVs), Interim Monitoring Visits (IMVs) and Closeout Visits (COVs)
  • Finalizing Monitoring Visit Reports within 15 Business Days
  • Ongoing Site Monitoring and Management
  • Remote Monitoring
  • Adverse Event (AE) and Serious Adverse Events (SAEs) Review
  • Monitoring of Site Recruitment and Enrollment Activity
  • Subject Recruitment and Retention Support
  • Protocol Deviations/ Violations Tracking
  • Reporting of Site Fraud and/ or Misconduct
  • Conducting Ongoing Training of Site Personnel
  • Source Document Verification and CRF Review
  • Query Management and Resolution Support
  • Review of Investigator Regulatory Files and Trial Master File (TMF) for Completeness
  • Clinical and Non-clinical Supply Management
  • Discuss Site Responsibilities and Requirements for Successful Study Conduct

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