May 8
Earlier this month, TransCelerate BioPharma released a summary report focused on selective safety data collection (SSDC) gathered during a joint tabletop exercise convened in late 2025 in collaboration with U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI).
Read the full article from Clinical Research News here.
Related Blog Posts
Why the biggest gains in clinical R&D won’t come from technology
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.
Enough, already: the problem with clinical trial data collection
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…
2026 DIA Global Annual Meeting: What the FDA’s Real-Time Data Push Actually Means for Sponsors and CROs
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…