The Top Line

Avoiding 11th hour surprises in clinical trials (Sponsored)

16 snips
Mar 23, 2026
Olive McCormick, Director of Quality and Qualified Person at Almac Clinical Services with deep IMP and regulatory experience. She discusses the new UK Clinical Trial Regulation and what it means for trials. Short takes cover transitional rules, labeling and imported inventory timing. Practical de-risking steps and how to engage sponsors, CROs and sites are highlighted.
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INSIGHT

UK Regulation Prioritizes Agility And Risk Proportion

  • The UK regulation aims to be more agile and risk-proportionate, prioritizing patient safety and faster trial starts.
  • MHRA created a streamlined pathway for low-risk notifiable trials to free expert review capacity for complex, high-risk studies.
ADVICE

Stand Up A Cross Functional Change Team Now

  • Establish a cross‑functional change team immediately to review the regulation line-by-line and assess impacts on operations and clients.
  • Revisit interpretations frequently as MHRA releases supplemental guidance and document consistent responses for sponsors.
INSIGHT

Top Sponsor Concerns Are Practical Transition Issues

  • Sponsors' top concerns center on transitional arrangements, labeling changes, and non‑investigational medicinal products (NIMPs).
  • Most questions are tactical and operational, focused on keeping ongoing trials uninterrupted during transition.
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