When the Manufacturing Site Fails, Your Enrollment Plan Fails With It
Novo Nordisk's Bloomington facility hit with another FDA 483 — here's how manufacturing findings cascade into site enrollment holds,...
Clinical Operations
When AI Picks Your Site, Execution Still Happens in the Building
ASCO and Ryght AI are using machine learning to select breast cancer trial sites. Here's what that means for...
When Your CRO’s Books Were Wrong, Your Trial Budget Probably Was Too
ICON's $158M revenue restatement across 2023–2024 exposes how CRO accounting gaps cascade into site payment delays, contract disputes, and...
Veeva Unveils Falcon AI Platform and Agentic Authoring at 2026 Summit
At the 2026 Veeva R&D and Quality Summit in Copenhagen, Veeva Systems announced three major AI capabilities: Vault AI,...
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...
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,...
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...
Novartis Restructures Clinical Ops to Scale Trial Innovation Beyond Pilots
Novartis built a dedicated Global Clinical Operations Innovation Team 18 months ago to move past one-off pilots and embed...