The 82x ROI Claim Every Oncology Sponsor Is About to Misread
Tufts CSDD puts 82x ROI on AI monitoring agents in Phase 3 oncology. Before sponsors restructure monitoring teams, sites...
Site Management
When Your CMO Fails an FDA Inspection, Your Sites Pay the Price
Scholar Rock's BLA refiling for SMA drug apitegromab after Catalent Indiana's OAI classification shows how CMO inspection failures translate...
What Icon’s $300M Microsoft Bet Means for the Sites Running Their Trials
Icon's enterprise-wide Microsoft Copilot deployment and $300M AI investment will reshape how CRAs monitor, query, and escalate — here's...
When Bad Protocol Design Hits Your Site, AI Won’t Save You
Phesi finds fewer than 1 in 3 trial protocols connect to real patient data — meaning flawed assumptions reach...
Europe’s 2030 Clinical Trial Targets Are Already Falling Behind — And the Clock Is Ticking
EMA's first 2026 quarterly report shows only 40.5% of EU trials recruiting within 200 days — far below the...