With the regulators moving forward with guidance on risk based monitoring, and the industry trend of
adopting this approach, this presentation will aim to demonstrate how the combination of CTMS, EDC
and analytics can be used to identify and manage site risk profiles. The presentation will draw from the
work completed by the MCC members and show how the Site Scoring tools for Site Selection and Study
Conduct can be used to generate a risk profile dashboard based on data from CTMS and EDC. The
presentation will further explore how data captured in CTMS and EDC can be used to update the risk
profile of the site during the course of the study, allowing the study team to proactively manage risk.