News

Amid mounting political and legal pressure, corporate DEI efforts, particularly in life sciences, are largely holding steady, with leadership, boards, and shareholders continuing to frame inclusion as a strategic driver of innovation, performance, and representative clinical research.

In today’s ACT Brief, we look at why durable signal closure is emerging as a defining metric in risk-based quality management, how AI can reduce startup delays without burdening sites, and how patient-centric drug design is reshaping the CDMO landscape.

Analysis of more than 880 clinical trials shows that while statistical data monitoring and key risk indicator signals close on similar timelines, durability—not speed—is the defining differentiator in effective, risk-based quality management.

Examine how practical AI applications can streamline contracts and startup workflows while preserving the central role of investigators, site staff, and patient relationships in clinical research.

In today’s ACT Brief, we look at efforts to address sex-based evidence gaps in Parkinson’s disease research, why communication failures continue to delay study startup, and how a new White House healthcare plan aims to reduce drug and insurance costs.

As Parkinson’s disease cases surge worldwide, growing evidence gaps around women’s biology, care access, and outcomes are driving new data-driven and digital strategies to advance sex-specific research and precision medicine.

Unpack why persistent communication breakdowns between sponsors, CROs, and sites undermine startup efficiency—and how bidirectional, site-informed engagement models can improve collaboration and momentum.

In today’s ACT Brief, we look at how AI is reshaping clinical trial registries into discovery tools, why contract and budget negotiations remain the biggest drag on site activation timelines, and how integrated data platforms are closing gaps across payer, provider, and patient care.

Explore how contract standardization, proactive budget alignment, and AI-enabled negotiation tools can reduce site activation delays and turn agreements into strategic accelerators rather than administrative bottlenecks.

In today’s ACT Brief, we examine what will separate sponsors that scale AI beyond pilots in 2026, break down the FDA’s new draft guidance on Bayesian statistical methods in clinical trials, and explore how poor planning and trial design continue to place operational strain on research sites.

The FDA’s new draft guidance on Bayesian methodology signals a shift toward more flexible, data-driven clinical trial designs, enabling sponsors to use prior data and adaptive approaches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

Pharmacovigilance has advanced in detecting population-level safety signals, but a critical gap remains in translating those insights into transparent, defensible patient-level decisions.

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.

In today’s ACT Brief, we examine the growing challenges of sourcing comparator drugs across the EU, highlight a new AI-driven oncology collaboration between BostonGene and AstraZeneca, and explore why AI life sciences companies are being pushed to prove real operational value beyond hype.

BostonGene has entered a new collaboration with AstraZeneca to apply its foundation AI model to oncology drug development, aiming to improve early trial decision-making around safety, efficacy, and biomarker strategy while accelerating clinical timelines.

Comparator drug sourcing in the EU is shaped by a defined set of availability, regulatory, competitive, and logistical pressures, alongside practical strategies to reduce risk and protect trial timelines.

In today’s ACT Brief, we examine why representative enrollment remains a barrier in US cancer trials, review Johnson & Johnson’s positive Phase IIb results for nipocalimab in systemic lupus erythematosus, and break down a new multibillion-dollar research and licensing agreement between Nimbus Therapeutics and Eli Lilly targeting oral obesity treatments.