When the Sponsor’s Name Changes Mid-Trial, Sites Pay the Operational Price
BioMarin's $4.8B Amicus acquisition closed April 27—now sites running Amicus trials face contract ownership gaps, monitoring voids, and enrollment...
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...
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...
When the Vendor Consolidates, Sites Feel It First
WCG's acquisition of The Contract Network promises faster trial startup—but site coordinators know vendor mergers rarely simplify the contracts...
When the Trial Says No but the Site Was Never Ready
The THEIA trial's negative alteplase result may reflect site execution failures more than drug biology—a CAPA lesson every ops...