Nov 18
Clinical trial protocols are among the most complex and resource-intensive documents developed in pharmaceutical and biotechnology research. Designed to define objectives, procedures, participant criteria, and data collection practices, protocols serve as the operational blueprint for evaluating investigational therapies. However, as the range of study endpoints has grown, so too has the volume, complexity, and burden of data collection placed upon research sites and participants.
Listen to the full podcast by Drug Discovery News 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…