Risk Based Monitoring: The Site Perspective

Presented by

Emer Doherty, Director, Project Management, ICON; Nycole Rameriz, Director Clinical Management, ICON

About this talk

Risk based monitoring has been emerging for years. The 2017 release of ICH E6 R2 introduced the world of technology to a 20-year-old guideline with increased focus on delivering quality and efficiencies in clinical trials. This webinar explores the evolution of centralised, risk based monitoring, specifically addressing the impact on sites, examining the growing pains, and fostering dialogue and awareness between CROs, sponsors and sites. Topics covered include: - Advancing our quest for quality management to continually improve the way we monitor clinical trials by placing emphasis on what really matters - Focusing on data and processes that are critical to patient safety and data integrity, putting the patient first - Leveraging technologies that enhance a quality-driven perspective and discussing what all of this means for the industry

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BioPharma companies and Medical Devices manufacturers face growing operational, regulatory and economic challenges when it comes to developing their drug or device. ICON provides analysis and key insights on these challenges, with practical advice and recommendations.