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....
site activation
Lilly’s Bet on Abridge Exposes the Recruitment Handoff Nobody Wants to Own
Eli Lilly invested in Abridge's AI recruitment tool — but the real question is whether sites can operationalize patient...
The Single Phase 3 Default Is Already Changing How Sites Get Activated — Are You Ready?
FDA's February 2026 single-trial default standard is compressing enrollment timelines and reshaping site contracts. Here's what ops teams must...
When Your CRO Gets Acquired Mid-Trial, the Site Pays the Operational Price
Tevogen Bio's MSO/CRO acquisition push signals a consolidation wave that will disrupt site activation, monitoring, and contracts mid-study. Here's...
When AI Scales Your Protocol, It Scales Every Flaw Inside It
Phesi's 2026 analysis found fewer than 1 in 3 trial protocols are linked to patient data—meaning AI tools are...
Mid-Trial Site Additions Sound Like Progress — The Activation Math Tells a Different Story
NKGen Biotech just added 3 Alzheimer's trial sites across NJ, NY, and FL. Here's what the activation math actually...
ICON’s San Antonio Expansion Looks Like Opportunity—Your IRB Timeline Says Otherwise
ICON opens early-phase units in San Antonio, Houston, and Lawrence, KS—but sponsors activating satellite clinics face IRB, contract, and...
When Gilead Cuts 108 Jobs at Arcellx, Your Trial Feels It Before You Know Why
Gilead's $7.8B Arcellx acquisition just cut 108 Redwood City jobs. Here's what that means for CAR-T trial sites running...
The Protocol Complexity Tax: What Sponsors Don’t See on the Site Invoice
Protocol complexity now drives 76% of trials to at least one amendment—here's what that costs sites in activation days,...
The Protocol That Ate the Timeline: How Scope Creep Becomes a Site Operations Crisis
76% of trials now require protocol amendments—and every one resets IRB clocks, contract cycles, and site activation timelines your...