Video
Continuous Oversight under ICH E6 (R3)
At the ³Ô¹Ï±¬ÁÏ Clinical Oversight Forum in Copenhagen, ³Ô¹Ï±¬ÁÏ¡¯s Pinar B¨¦net explored how sponsors can operationalize R3 in highly digital, outsourced environments¡ªby 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¡ªand 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¡ªand 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 ¡ª agile systems enable sponsors to act fast and proactively.¡± Pinar B¨¦r¨¦nice B¨¦net, Senior Director Clinical Strategy, ³Ô¹Ï±¬ÁÏ
Learn more about oversight and collaboration at ³Ô¹Ï±¬ÁÏ R&D and Quality Summit, Copenhagen, 28-29 May, 2026. Register now.