Merck Reporting on Site Monitoring, Performance and Database Lock

In this session recorded at DPHARM 2021, Merck shares about their proprietary Site Monitoring and Reporting Tool (SMART), an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. Merck talks about how they got SMART. Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck addresses how this really helped in COVID-19. Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021). Merck shares with the DPHARM audience how this worked. 

Speakers

• Andrew Onikepe, Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), Merck
• Merle Schneider, Director, Monitoring Excellence Innovation, Merck
• Katherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck