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This violation of the "Segregation of Duties" principle is a primary driver of data integrity enforcement under 211.68(b)

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A Foundation of Unmatched Quality Control Having our own lab gives us direct, uncompromising control over the entire cellular production chain

Looking Ahead What Sponsors Should Prepare For in 2026 Expect stronger focus on: Adaptive and Decentralized Trial Designs (DCTs) Digital endpoints and real-world evidence Inclusive recruitment strategies Clear dose-optimization rationale, especially in oncology At Tigermed EMEA, we continue to invest in innovative operational models, digital ecosystems, and regulatory intelligence to ensure our partners stay ahead of evolving global requirements.