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
