AB Science’s “Calendar Update” Is a GCP Inspection Disclosure in Disguise
AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three...
GCP Compliance
The EU Just Revoked Tavneos. What Did FDA Know During the Parallel Review?
EMA revoked Tavneos (avacopan) in August 2026 over GCP breaches in the pivotal ADVOCATE trial. FDA approved the same...
When the Consent Form Is the Catastrophe: What Alembic’s FDA Warning Letter Means for Your Site
Alembic's July 2026 FDA warning letter on informed consent failures at its Vadodara BE facility exposes the GCP documentation...
The Informed Consent Warning Letter Every Site Director Should Read Twice
FDA's July 2026 warning letter to Alembic's bioequivalence site exposes informed consent failures that can ground any trial. Here's...
Ambient AI Is Not Losing Your Trial Data. It’s Quietly Deciding What Counts.
Ambient AI scribes reduce physician burnout—but a Lancet case reveals they systematically drop psychosocial context that drives protocol adherence...
GCP Breakdown at King’s College Hospital Just Clouded the Most Promising Parkinson’s Trial in Years
An MHRA inspection at King's College Hospital flagged department-wide GCP failures in the exenatide Phase 3 Parkinson's trial, triggering...
The FDA’s One-Day Inspection Pilot Will Catch Sites That Aren’t Ready — Starting Now
FDA's BRIDGE one-day assessment pilot launched April 2026, compressing traditional 3-6 day inspections. Here's what sites must change before...
The FDA’s One-Day Inspection Pilot Will Expose Every Site That Built Readiness for a Five-Day Visit
FDA's April 2026 one-day inspection pilot compresses what sites have 5 days to prove into a single visit—here's what...
The ICU Trial That Should Embarrass Every Sponsor Hiding Behind “Ethical Complexity”
A JAMA RCT on ICU restraint strategies just proved rigorous trial design works even in critically ill patients —...