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 recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine ...
In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data ...
FDA proof-of-concept trials with AstraZeneca and Amgen validate continuous data transmission and signal detection, setting ...
In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol ...
In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains why scaling pragmatic and decentralized trial approaches, not just piloting them once, ...
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 this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains how four jointly developed regulatory scenarios give sponsors a blueprint for adopting ...
In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing ...
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