Mar 7
03/17/2025
Every International Women’s Day invites reflection: Where have we made strides toward equity, and where do critical gaps remain? In clinical research, we see clear and sometimes sobering examples of how important these reflections can be. Until 1993, women weren’t even required to be included in U.S. clinical trials — an eye-opening fact that illustrates how recently the pursuit of truly representative research began.
Read the full article by Allison Cuff Shimooka from MedCity 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…