Monitoring
Ensure Accuracy of Your Trial Data and Compliance with Study Requirements – Catch and Resolve Issues Efficiently
Effective monitoring is the key to high quality study data. GBC develops efficient and risk-based monitoring plans by looking at anticipated enrollment rates and available resources across a given trial network. GBC’s custom approaches increase trial quality and efficiency. GBC monitoring builds confidence in partner performance while cultivating compliance and ongoing commitment.
Site Monitoring Services
GBC monitoring services involve coordination with site managers and local coordinators, a detailed on-site review of study documentation, and follow-through for resolution of observations and deviations. GBC site monitoring services include:
- Coordination of Monitoring Visit Travel
- Review of Enrollment Progress
- Review of Regulatory Documents
- Review of Relevant Source Documents (SDs)
- Data Verification to Ensure Accuracy (Data Monitoring)
- Review of Investigational Product and Study Supply Accountability
- Review of Monitoring, Maintenance, and Calibration Records for Study Site Equipment and Instruments
- Review of Site Deviations, Deviation Reports, and Deviation Logs
- Review of Adverse Event (AE) Reports and Follow-Up
- Documentation and Resolution of Data Discrepancies
- Preparation and Delivery of Site Monitoring Report
- Coordination of Regional Trial Monitors
Risk-Based Monitoring Approaches
- Study and site specific monitoring plans
- Predicting and preventing critical issues before they happen, not after they happen
- Adapting the type, frequency, and intensity of monitoring to best address critical issues
Study Deviation Tracking and Resolution
GBC helps sponsors to identify noncompliance issues and implement strategies to resolve them and prevent recurrence.
For additional information on GBC's clinical trial services please contact trials@globalbioclinical.com or register and send us your inquiry here.