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...
Moe Alsumidaie
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...
Semaglutide Just Passed Its Hardest Test Yet — And the FDA Has No Roadmap for What Comes Next
A landmark Lancet RCT shows once-weekly semaglutide cut heavy drinking days in 108 AUD-plus-obesity patients. The FDA approval path...
The Eight Hours Clinicians Ignored: How Albus Health Is Turning Sleep Into a Clinical Endpoint
Mikesh Udani CEO, Albus Health For decades, respiratory medicine has measured what patients do during the day—spirometry in clinic,...
The Disease-Modification Bet in Pulmonary Arterial Hypertension
Sten R. Sörensen CEO and Board Member, Cereno Scientific Pulmonary arterial hypertension kills most patients within seven years of...