In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol ...
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 ...
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 ...
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 ...
FDA proof-of-concept trials with AstraZeneca and Amgen validate continuous data transmission and signal detection, setting ...
In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine ...
Clinical data security built into system architecture from the foundation, rather than layered on afterward, reduces regulatory risk and actually accelerates research by removing manual compliance ...
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