New findings from a Phase II study indicate that antenatal treatment with the FcRn blocker nipocalimab resulted in low fetal drug exposure and transient reductions in infant IgG levels at birth, ...
Charlie Paterson, partner at PA Consulting, discusses how fewer new guidance updates are pushing sponsors to rely on historical precedents and non-US standards when making trial design and operational ...
In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and ...
Certain low-risk or mature devices may see reduced trial requirements, but the broader trend is toward augmenting—not ...
As trials expand into new geographies and decentralized models mature, sponsors are confronting a core operational challenge in 2026: how to scale global execution while reducing system complexity and ...
In today’s ACT Brief, we look at how real-world evidence is reshaping trial design rather than replacing trials, what Worldwide Clinical Trials’ acquisition of Catalyst Clinical Research signals for ...
The FDA and EMA have aligned on ten guiding principles for the responsible use of artificial intelligence across the drug development lifecycle, establishing a shared framework to support innovation, ...
Charlie Paterson, partner at PA Consulting, explains how reduced FDA capacity and staff turnover have led to longer regulatory timelines, increased preparation for agency interactions, and delayed ...
Methodological transparency is critical. Sponsors must document how cohorts were built, how missingness was handled, and how ...
In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, ...
In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global ...
Worldwide Clinical Trials has entered into a definitive agreement to acquire Catalyst Clinical Research, a specialized oncology-focused contract research organization (CRO), in a move aimed at ...
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