Oct 15
10/15/2025
In an industry driven by scientific curiosity and innovation, the notion that too much data could be a drawback is almost blasphemy. But with a single phase 3 trial now generating nearly six million data points, it may be time to pare down protocols, according to a new study.
Read the full article by PharmaVoice here.
Every few years, the clinical research industry rallies around a new wave of innovation. From decentralised trials and digital biomarkers to AI driven automation, each wave brings genuine capability andpromise. Read the full article featuring Kelsey Jakee on page 38 here.
The clinical research ecosystem has never been more technologically capable — or more burdened by its own ambition. In December 2025, the Tufts Center for the Study of Drug Development and our team at TransCelerate published research that suggests nearly 30% of the data collected in clinical trials do not directly inform key decisions, yet patients are…
In this video interview from the 2026 DIA Global Annual Meeting, Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate’s Embedded Pragmatic Trials initiative, reframes the FDA’s continuous review expectations around real-time evidence generation and explains why quality by design—not data cleanup—is what regulators are now demanding. Watch…