Continuous Oversight under ICH E6 (R3)

At the Veeva Clinical Oversight Forum in Copenhagen, Veeva’s Pinar Bénet explored how sponsors can operationalize R3 in highly digital, outsourced environments—by modernizing systems, rethinking legacy mindsets, and embracing proactive quality by design.

Discover:

• Why timely access to operational data is the foundation of effective, risk-based oversight under R3 (00:22)
• How sponsors can maintain oversight in fully outsourced models using CTMS Transfer and connected systems (01:11)
• The growing trend of bringing clinical data management in-house to strengthen accountability and data standards (01:53)
• Why legacy “waterfall” systems block agility—and how modern platforms enable faster amendments and collaboration (03:34)
• How R3 shifts quality from reactive compliance to proportionate, study-specific risk management (05:36)
• What sponsors most misunderstand about continuous oversight—and why industry-wide execution standards are still emerging (08:57)
• How connected clinical platforms support cross-functional collaboration and a sustainable culture of quality (10:31)

“The biggest mindset shift is moving from waterfall to agile ways of working — agile systems enable sponsors to act fast and proactively.” Pinar Bérénice Bénet, Senior Director Clinical Strategy, Veeva

Learn more about oversight and collaboration at Veeva R&D and Quality Summit, Copenhagen, 28-29 May, 2026. Register now.