In today’s ACT Brief, we examine how large de-identified datasets are reshaping trial design and site strategy, why global pharmaceutical production is expected to cool after a tariff-driven surge, and what FDA’s new M4Q(R2) draft guidance means for quality submissions.
Acknowledging the need to optimize decentralized adoption of innovation in clinical research.
Explore how large-scale, de-identified real-world datasets enable more representative trial design, improve site selection, and support patient identification beyond the limits of traditional clinical study populations.
In today’s ACT Brief, we look at how FDA policy is accelerating the use of de-identified real-world evidence in clinical development, why a new bipartisan funding package could stabilize federal research agencies, and how the US withdrawal from the World Health Organization reshapes global health coordination.
A bipartisan spending package would modestly increase 2026 funding for HHS, including targeted gains for NIH and CDC programs, as lawmakers move to avert a government shutdown after a year of proposed cuts and operational disruption.
Examine how the FDA’s acceptance of de-identified real-world evidence shifts clinical operations workflows and why understanding the difference between pseudonymized and anonymized data is now critical for privacy, compliance, and evidence generation.
In today’s ACT Brief, we look at how global clinical development is evolving through decentralized models and emerging markets, why site-centric practices are becoming critical to faster study activation, and how a new Pfizer–Novavax agreement reflects shifting vaccine development strategies.
Global clinical development has evolved into a technology-enabled, highly regulated, and geographically diversified enterprise, as sponsors adapt trial design, partnerships, and operations to meet rising demands for scale, speed, and patient-centricity.
Consider how sponsor and CRO practices that prioritize site needs, clarity, and partnership can strengthen trust, sustain momentum, and speed activation without sacrificing the human experience.
In today’s ACT Brief, we examine why life sciences companies are maintaining DEI commitments amid political pressure, what’s driving longer site activation timelines and how sponsors can reverse the trend, and how FDA and EMA are aligning on principles for AI use in drug development.
Analyze the operational pressures driving longer activation timelines, from protocol complexity to site competition, and learn how earlier, more flexible site engagement can restore momentum.
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.
As AI-driven search becomes the primary way patients discover research opportunities, the quality and structure of clinical trial registry data will determine whether transparency translates into real, equitable access.
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.
