May 28
06/15/2026
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 the full interview from Applied Clinical Trials 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.
Clinical research has no shortage of technology. What it lacks is the ability to scale in ways that allow information to flow automatically across systems and support digitally enabled workflows for critical stakeholders. Read the full article featuring Rob DiCicco from Clinical Trials Arena here.
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…