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,...
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Your Recruitment Plan Is Failing Before Screening Even Starts
59% of sites report recruitment blocked by process inefficiencies—the bottleneck isn't patient supply, it's the workflow that never gets...
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...
When Your CRO Merges Mid-Study, the Site Pays the Price
Caidya and Simbec-Orion's merger creates a 6-month operational danger zone for sites running active studies. Here's what sponsor clinops...
When Two CROs Become One, Sites Pay the Integration Tax
Caidya and Simbec-Orion's June 2026 merger creates real site-level friction: dual CTMS logins, monitoring model gaps, and budget renegotiations...
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 Drug Supplier Gets a Warning Letter: What Genzyme Ireland Means for Trial Supply Planning
FDA issued a Warning Letter to Genzyme Ireland on June 22, 2026, over CGMP violations at its Waterford site....
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...