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