The Genetics Are Global. Your Enrollment Plan Isn’t.
A landmark Lancet Neurology study exposes the operational gap in Parkinson's trials: ancestry-based biomarker screening built for European cohorts...
Site Operations
The Genetic Trial Diversity Problem Is Now a Site Operations Problem
A 99,783-person multi-ancestry Parkinson's study just exposed a critical enrollment gap: GBA1 and LRRK2 trials run almost exclusively in...
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...
When the Phase 3 Dies After the Acquisition: The Site-Level Fallout No One Plans For
GSK's Phase 3 termination of camlipixant after its $2B Bellus Health buyout triggers an operational cascade—site deactivation, IRB amendments,...
59% of Sites Are Losing Patients Before They Ever Screen — Here’s Where the Pipeline Actually Breaks
A new survey finds 59% of clinical trial sites lose eligible patients to process failures. Krishma Shah breaks down...
The $10B Integration Problem Vertex Hasn’t Solved Yet
Vertex's $10B Crinetics acquisition doubles its therapeutic footprint overnight. Here's what that means for site contracts, CTMS consolidation, and...
When the Manufacturing Site Fails, the Clinical Site Pays the Price
Sanofi's Genzyme Ireland 483 and June 2026 warning letter show how CGMP failures at a manufacturing facility cascade into...
When Your Sponsor Gets Acquired Mid-Trial: The Operational Playbook Sites Need Now
Zymeworks' $929M acquisition of Theravance, whose R&D was already shut down, puts active trial sites in a familiar operational...
When Your CRO’s AI Platform Upgrades, Who Pays for the Change Management?
Icon's Microsoft-Copilot partnership scales its Orbis AI platform enterprise-wide. For sites and sponsors mid-trial, the operational cost question starts...