When the Factory Holds Up the Approval, Your Sites Are Already Paying for It
FDA extended Novo Nordisk's denecimig review over manufacturing remediation. Here's what sponsor clinops teams must do before the new...
site readiness
The ICON-Anthropic Deal Will Reach Your Site Before You’re Ready for It
ICON's multi-year Claude deployment will reshape eTMF workflows, protocol timelines, and site data ops. Here's what coordinators need to...
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 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...