Certain low-risk or mature devices may see reduced trial requirements, but the broader trend is toward augmenting—not ...

Methodological transparency is critical. Sponsors must document how cohorts were built, how missingness was handled, and how ...

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, ...

In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and ...

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 ...

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, ...

Explore how large-scale, de-identified real-world datasets enable more representative trial design, improve site selection, ...

In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s ...

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 look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical ...

In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging ...