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.

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Copenhagen | 28-29 May, 2026

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