Clinical Monitoring Oversight Toolkit
A biotech company elected to outsource their clinical study monitoring. As a result, the company needed a toolkit for internal use to evaluate and monitor the quality of the outsourced monitoring effort.
Halloran developed a Clinical Monitoring Oversight Toolkit which provided:
- Guidance on best practices to evaluate the quality of outsourced clinical monitoring.
- Specific instructions for conducting a monitoring-oversight visit.
- A risk-based analysis of how and where to selectively evaluate sites and/or monitoring activities.
- A monitoring oversight checklist, which identified site and monitor activities to observe during a monitoring oversight visit. General and study-specific activities were identified.
As a result of receiving their toolkit, the company ensured that study monitoring consistently provided quality site oversight and data integrity across all clinical studies moving forward.