When You Change the Endpoint at Month 12: What CHOICE-2 Got Right About Amendment Governance
CHOICE-2 changed its primary endpoint after 283 enrollments with no interim data released. Here's what that timeline reveals about...
Clinical Operations
“Hard to Reach” Is a Sponsor Operations Failure, Not a Population Problem
The Lancet calls out "hard to reach" as a stigmatizing label. For clinical ops, it's a site selection failure...
AI in Clinical Trials Doesn’t Have a Capability Problem. It Has a Honesty Problem.
Six AI models picked the same "random" number. Clinical ops leaders are finally asking what that reveals about every...
What Merck and SCRI’s Community Network Deal Actually Means for Site Operations
Merck and SCRI's Accelero™ collaboration targets community oncology enrollment, but the real test is whether 200+ sites can execute...
When Your CRO Gets Acquired, Your Site Activation Timeline Pays the Price
Curavit's acquisition of Lindus Health CRO assets combines 1,000+ global sites with DCT infrastructure—but site teams absorb the operational...
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...
When Two CROs Become One, Sites Pay the Integration Tax
Caidya and Simbec-Orion's June 2026 merger creates real site-level friction: dual CTMS logins, monitoring model gaps, and budget renegotiations...
The CRO Isn’t Failing Your Trial. Your Governance Model Is.
Sponsors treat CRO contract signing as a handoff. Three independent clinical ops leaders say that abdication, not bad molecules,...
Why Pilots Don’t Scale: The Case for Pre-Protocol Invariants in Clinical Development
A leading sponsor hit 79% site adoption and called it a ceiling. The fix isn’t better tools—it’s pre-protocol invariants...
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...