The 90% Automation Promise Means Nothing to a Coordinator Running 12 Systems
Medable's CEO wants 90% of clinical trials automated by 2030. Site coordinators are still manually bridging 12 disconnected systems....
Site Operations
When Your CRO Gets Acquired Mid-Study, Your Site Feels It First
Curavit's acquisition of Lindus Health's CRO assets unifies 13,478 sites across 79 countries — but site teams will navigate...
The 82x ROI Claim Looks Great on a Slide Deck — But Who’s Paying for the Infrastructure at the Site?
Tufts CSDD says AI monitoring agents deliver 82x ROI in Phase 3 oncology. But that number assumes sites can...
When Your CRO’s AI Sends a Query, Who’s Accountable for the Answer?
ICON's Anthropic partnership deploys Claude into clinical trial monitoring. Here's what site coordinators and ops leads need to verify...
What ICON’s Claude Deal Actually Means for the Site Coordinator Running Your Trial
ICON's Anthropic partnership deploys Claude AI into clinical trials. Here's what it means for EDC workflows, IRB docs, and...
Your Biometrics Vendor Is Not Built for What Your Next Trial Requires
Acrosian's AI-native CRO launch forces a real question: can legacy biometrics vendors support DCT-era data demands, or is your...
The Genetics Are Global. Your Enrollment Plan Isn’t.
A landmark Lancet Neurology study exposes the operational gap in Parkinson's trials: ancestry-based biomarker screening built for European cohorts...
The Genetic Trial Diversity Problem Is Now a Site Operations Problem
A 99,783-person multi-ancestry Parkinson's study just exposed a critical enrollment gap: GBA1 and LRRK2 trials run almost exclusively in...
When the Consent Form Is the Catastrophe: What Alembic’s FDA Warning Letter Means for Your Site
Alembic's July 2026 FDA warning letter on informed consent failures at its Vadodara BE facility exposes the GCP documentation...
The Informed Consent Warning Letter Every Site Director Should Read Twice
FDA's July 2026 warning letter to Alembic's bioequivalence site exposes informed consent failures that can ground any trial. Here's...