When the Trial Fails, Was It the Drug or the Design?
NetraMark's Chief Innovation and Regulatory Officer Luca Pani, MD, on why broad enrollment can obscure treatment effects, what makes...
Moe Alsumidaie
When the Trial Ends, the Data Work Begins
Dr. Olga Kubassova, Founder and CEO of Image Analysis Group (IAG), discusses how AI-driven imaging biomarkers extend the value...
FDA Hears 80 Speakers on Psychedelic Drug Therapy Standards
The FDA held a public hearing on psychedelic drug therapy, drawing more than 1,800 registered attendees and 80 speakers...
DYNAMIKA™: The Operating System for Imaging Clinical Trials
Sponsored by Image Analysis Group. Why the imaging platform decision is the single most consequential infrastructure choice a sponsor...
In Vivo CAR-T for CNS Autoimmune Disease Looks Promising. The Trial Design Problem Is Hiding in Plain Sight.
NEJM's lentiviral in vivo CAR-T data in neurologic autoimmune disease is compelling, but the trial infrastructure to validate it...
Veeva Launches Falcon Safety AI for Adverse Event Processing Across E2B Systems
Veeva Falcon Safety will streamline adverse event processing across E2B-compliant safety systems, including Oracle Argus and ArisGlobal LifeSphere.
When the Site Is Also the Sponsor: Princess Máxima’s Rinke Riezebos on Data Standardization, Protocol Design, and Why Sponsors Should Listen to Their Sites
Princess Máxima Center for Pediatric Oncology is both sponsor and site, and that dual vantage point gives Rinke Riezebos...
The Standards Gap Is the Strategy Gap
Veeva's regulatory and policy leads on AI accountability, FDA uncertainty, and why fragmentation is the real competitive threat
Why AI Readiness Starts with the Digital Foundation
AOP Health's VP of Digital on why platform consolidation has to come before the AI conversation
Psychedelic Trials Are Effectively Open-Label. The FDA Has to Decide What to Do With That.
A meta-analysis of 112 psychedelic RCTs found >90% unblinding rates, meaning every efficacy estimate in the field may be...