Veeva's regulatory and policy leads on AI accountability, FDA uncertainty, and why fragmentation is the real competitive threat

Sanofi's Genzyme Ireland 483 and June 2026 warning letter show how CGMP failures at a manufacturing facility cascade into...

FDA adopts ICH E6(R3) guidance, redistributing trial accountability across sponsors, sites, and vendors with new data governance requirements.

Clinical trial software market expands beyond large sponsors, reaching $900M in 2024 with SaaS deployment enabling smaller research sites...

Nature Medicine's immune aging biomarker framework challenges sponsors to redesign geroscience trials around surrogate endpoints the FDA hasn't yet...

Ascletis files two IND applications for once-monthly obesity drugs targeting three receptors with a single injection, showing 51% greater...

SaaS adoption in clinical trials raises data security and regulatory compliance questions for sponsors using cloud-based platforms.

Federal funding cuts and regulatory changes intensify trial complexity at clinical research sites entering 2025, threatening study timelines and...

DSMB recommends continuing 60 Degrees' tafenoquine trial for chronic babesiosis after safety review of interim data through Day 30.

Harvard's COMPASS AI predicts checkpoint inhibitor response across 33 cancer types with 8.5% better accuracy—but translating that into trial...