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The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches to improve efficiency, reduce timelines, and support regulatory decision-making.

See what will distinguish sponsors that scale AI into core operations from those stuck in experimentation, and why redesigning underlying processes—not just optimizing workflows—is critical to realizing long-term value.

In today’s ACT Brief, we look at how community research sites can stay competitive under efficiency pressure, why 2026 is shaping up as a turning point for platform-based clinical operations, and how AI is being positioned to better match patients to therapies.

The clinical trial ecosystem is entering a phase of consolidation and reinvention driven by the collapse of boundaries between functions, data, and even companies themselves.

In today’s ACT Brief, we examine how community research sites can stay competitive under rising efficiency pressures, why clinical outcome assessment licensing remains a drag on trial start-up, and what’s holding back AI-driven pharmacovigilance at scale.

Examine the strategies community research sites can use to secure trial opportunities, from adopting AI-enabled workflows to proving verified access to underrepresented patient populations.

Persistent delays and inefficiencies in COA licensing and translation stem from limited pre-license access and fragmented processes, making a strong case for providing outcome assessment measures earlier to reduce risk and accelerate trial start-up.

Learn how real-time patient eligibility data is reshaping trial planning and site selection, allowing sponsors to design more inclusive studies based on current patient reality rather than past performance.

In today’s ACT Brief, we look at how growing trial competition is undermining AI-driven efficiency gains, why pharmacovigilance is shifting toward patient-level causal reasoning, and what AI life sciences companies must demonstrate to stand out in a crowded market.

Unpack how rising competition for the same high-profile sites is slowing startup and enrollment—and what sponsors must change in their site strategies to ensure AI-enabled efficiencies translate into real-world impact.

In today’s ACT Brief, we hear how sponsors may redefine efficiency to protect patient access in 2026, review Verana Health’s merger with COTA to expand real-world evidence capabilities, and examine FDA’s latest decision on Vanda’s Hetlioz for jet lag disorder.

Verana Health’s merger with COTA expands real-world data and analytics capabilities across oncology and specialty care, strengthening research-ready evidence generation for biopharma, regulatory decision-making, and clinical development.

Explore how sponsors can recalibrate efficiency efforts to avoid overconcentrating trials at familiar sites and instead expand access through community partnerships, point-of-care research, and intentional outreach models.