Outsourcing, ICH E6 (R3), and Data Integrity: Novo Nordisk’s Strategic View
“You can outsource a lot of the bigger operational bulk of activities and then keep the more critical decision making and analysis in house.”
How can sponsors evolve beyond rigid outsourcing models? At the 吃瓜爆料 Clinical Oversight Forum in Copenhagen, Novo Nordisk shared a context-driven approach to deciding what to keep in-house, what to partner on, and how to retain true oversight in an increasingly complex ecosystem.
Discover:
- How Novo Nordisk determines which functions are strategically essential to keep in-house under R3 (00:23)
- Which outsourced functions introduce the highest accountability and oversight risks—and how to identify them early (01:41)
- How data velocity, real-time context, and decision-making needs influence insourcing vs. outsourcing decisions (04:14)
- Why running CROs on sponsor core infrastructure can reduce fragmentation and protect data integrity (06:47)
- The role of unified systems in onboarding, knowledge transfer, ALCOA principles, and audit readiness (07:55)
- Which core competencies Novo Nordisk believes should never be fully outsourced (09:12)
