Applied Clinical Trials

In today's ACT Brief, we examine how a gradual, win-driven strategy scales real-time monitoring adoption, why consumer wearables need rigorous fit-for-purpose validation, and an FDA committee's favorable vote on Replimune's oncolytic virus combinatio... more

In today's ACT Brief, we examine why real-time monitoring scales only through coordinated ecosystem efforts, how organizational failures not models explain weak AI results, and FDA's advisory panel peptide compounding decision.

In today's ACT Brief, we examine how sustainability is shifting from compliance to a procurement driver, what infrastructure gaps remain in FDA's real-time pilot model, and regulatory guidance targeting unnecessarily restrictive cancer trial criteria... more

In this pilot episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Paulo Limgenco, VP of Business Operations and ESG Strategy Lead at YPrime, about how sustainability is shifting fro... more

In today's ACT Brief, we examine how data standardization must precede real-time monitoring deployment, why contracts cannot transfer sponsor oversight responsibility, and a strategic acquisition broadening immunology development.

In today's ACT Brief, we examine the data collection-to-analysis gap undermining continuous trial monitoring, why AI agents require foundational workflow infrastructure, and FDA approval of a novel ADHD treatment.

In today's ACT Brief, we examine how inspection readiness must accumulate rather than assemble, why AI initiatives stall without disciplined governance, and what US clinical trials need beyond isolated initiatives.

In today's ACT Brief, we examine why execution failures originate upstream despite surfacing downstream, how European health data frameworks transform CRO roles, and why US trial competitiveness varies by development phase.