If you're running trials with predictive markers, PD endpoints, or potential companion diagnostics, here's what changed:

The ICH E6(R3) guidance (Step 4, January 2025) raised the bar for biomarker rigor.

If you're running trials with predictive markers, PD endpoints, or potential companion diagnostics, here's what changed:

🎯 "Fit for purpose" is now mandatory - Your biomarker assays need documented validation or clear justification. No more "we'll figure it out later."

📋 Critical-to-quality designation - If your biomarker drives key decisions, it gets enhanced oversight. Plan accordingly.

🔬 Sample chain-of-custody matters - Every step from collection to analysis needs documentation. Missing links = compliance gaps.

📊 Data integrity applies to everything - Digital biomarkers, wearables, central lab data—all must meet ALCOA+ principles.

📝 Informed consent got specific - Participants need clear explanations about biomarker use, genetic data handling, and future research plans.

This isn't just paperwork—it's about building trials that can actually support regulatory submissions.

Are your current biomarker processes ready for this level of scrutiny?