Clinical Monitoring Oversight Toolkit

SITUATION:

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.

SOLUTION:

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.

VALUE:

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.