Protocol design does not struggle in the protocol. It struggles in the transition to trial, when assumptions embedded in the ...

In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data ...

NEJM editors cited post–database lock readjudication after trial unblinding, undisclosed to two academic authors, as inconsistent with proper research conduct and sufficient to retract the publication ...

In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine ...

FDA proof-of-concept trials with AstraZeneca and Amgen validate continuous data transmission and signal detection, setting ...

Elisabeth Coart, PhD | Authors | Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, management, and monitoring.

In today's ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment. This is the Applied ...

In this Q&A, Raj Indupuri, CEO and co-founder of eClinical Solutions, discusses what the FDA's push toward continuous data review actually demands of sponsors operationally, why fragmented systems are ...

In this video interview following the 2026 DIA Global Annual Meeting, Jonathan Andrus, co-CEO of CRIO, explains why ...

In today's ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO ...