Whitepapers

Managing a modern clinical trial can feel a bit like herding cats. Every vendor brings specialized expertise, but each also has its own processes, priorities,

Despite the clinical trial industry’s rapid transformation over the last decade, the fundamentals of the Trial Master File (TMF) haven’t changed. Regulators still expect a

Clinical development teams are under increasing pressure from multiple directions, and it’s starting to change how their work gets done. While outsourcing was once a

All emerging biotechs face a similar challenge: they’re expected to build pharmacovigilance (PV) infrastructure that meets the same regulatory standards as large pharmaceutical companies, but

Sponsors and contract research organizations (CROs) have depended on each other for more than 30 years to bring therapies to market. But the relationship has

When the FDA published the ICH E6 R3 guideline in September of 2025, it illustrated how much clinical trials have changed over the last decade.