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
Moe Alsumidaie
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...
Decentralized Trials Are Everywhere. Nobody Agrees What They’re For.
DCTs promise faster enrollment and broader diversity, but sponsors, CROs, sites, and regulators each want something different—and the TELEPIK...
The Data Is Already There. The Question Is Whether You Can See It
A Vanguard Publications Q&A with Naomi, eClinical Solutions.
FDA’s May 2026 Leadership Exodus: What the Simultaneous CDER and CBER Vacancies Mean for Sponsor IND Strategy
With Makary out May 12 and acting CDER chief Høeg fired May 15, sponsors with pending NDAs and INDs...
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,...
The Brain Needs Fertilizer, Not Just a New Molecule
A Vanguard Publications Q&A with Madelyn, Neuro-Innovators.
The FY2024 BIMO Report Confirms It: Sponsor Oversight Failures Are Now Structural
FDA's FY2024 Bioresearch Monitoring report shows 25% of sponsor inspections drew a Form 483, with the same recurring findings...
Semaglutide’s Alcohol Data Is Stronger Than Anyone Expected — and the FDA Has No Playbook for It
A landmark Lancet RCT shows once-weekly semaglutide cuts alcohol use in obesity patients with AUD. The FDA's regulatory pathway...