FDA’s Advisory Committee Rebuild Will Reshape Protocol Feedback Before Sponsors Realize It
FDA's September 2026 adcomm recruitment push signals shifts in protocol feedback loops that sponsor clinops and sites can't afford...
The Pragmatic Trial Has Been Hijacked. Here Is What It Was Actually Supposed to Do.
JAMA's 2026 editorial exposes how "pragmatic trial" has been stretched beyond recognition, threatening regulatory credibility and real-world evidence quality.
AI Deployment in Clinical Studies Requires Validation Framework and Governance Structure
AI deployment in clinical studies requires validation framework and governance structure to address compliance gaps and enable safe implementation.
CRScube, Mednet demo integration-free EHR-to-EDC tool Oct 14
CRScube and Mednet demonstrate integration-free EHR-to-EDC tool designed to reduce manual transcription errors and streamline clinical data capture.
Oculis to Present Licaminlimab Data at AAO 2026 Meeting
Oculis to present licaminlimab data at AAO 2026 following year-end PREDICT-1 readout in genotype-selected dry eye patients.
Rezdiffra Shows Consistent Efficacy Across MASH Genetic Risk Variants
Rezdiffra shows consistent efficacy across common MASH genetic risk variants in Phase 3 analysis, addressing prescribing concerns for high-risk...
Astellas Presents Enfortumab Vedotin-Pembrolizumab Data at ESMO 2026
Enfortumab vedotin-pembrolizumab shows durability advantage over chemotherapy at three-year follow-up in bladder cancer trial EV-302.
Updated C-POST Survival Data for Cemiplimab in High-Risk CSCC Due at ESMO 2026
Regeneron will present updated C-POST overall survival data for adjuvant cemiplimab in high-risk CSCC at ESMO 2026 on October...
The FDA Created an AI Office. Now Comes the Hard Part.
CDER's new Office of Innovation and Clinical Trial Modernization fuses AI and RWE policy under one roof. That structural...
The Invoiceable Section Is Where Sites Leave Money on the Table
Most sites undercharge on research-paid items because no one reconciles the sponsor budget against the charge master. Here is...