In today's ACT Brief, we explore how Bayesian methods are reshaping FDA interactions and trial design, quality tolerance limits are becoming operational guardrails in risk-based quality management, and leadership transitions at the FDA's Center for Biologics Evaluation and Research signal evolving regulatory priorities.
In today's ACT Brief, we explore the operational capabilities clinical teams need to implement Bayesian trial designs, why gender diversity strengthens data science across drug development, and the FDA's rejection of external controls for a Huntington's gene therapy candidate.
In today's ACT Brief, we explore how Bayesian approaches are powering studies in rare disease and pediatrics, a major public-private initiative is standardizing digital endpoints for regulatory acceptance, and the FDA intensifies enforcement against misleading GLP-1 marketing.
In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is improving data flow and accuracy, and FDA approval standards continue to evolve.
In today’s ACT Brief, we highlight how Bayesian methods are gaining operational traction, a major patient advocacy merger is streamlining clinical trial access, and machine learning is reshaping trial design through multi-modal data integration.
In today’s ACT Brief, we examine how the Verana Health-COTA merger is evolving real-world data use, the FDA’s new framework for individualized ultra-rare disease therapies, and what a decade of cross-industry collaboration reveals about the future of clinical development.
In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.
In today’s ACT Brief, we explore how Bayesian trial designs are gaining traction in rare disease research, what priorities clinical operations leaders should focus on in 2026, and how rare disease science is shaping broader drug development strategies.
In today’s ACT Brief, we explore how sites are taking the lead on AI adoption to strengthen feasibility and enrollment, why earlier cross-functional alignment is critical in data-driven trials, and how Phase I strategy is shifting toward quantitative evidence generation.
In today’s ACT Brief, we examine how fragmented data collection continues to challenge trial quality, how hybrid outsourcing and AI are reshaping execution strategies, and why calls are growing for a risk-based FDA pathway for early-stage studies.
In today’s ACT Brief, we examine how protocol-driven eSource is reshaping data capture at sites, how digital protocols and data sharing are redefining trial execution, and how a Duchenne study termination highlights growing operational risks in rare disease development.
In today’s ACT Brief, we examine how site-level data capture is becoming central to trial execution, how Merck and Mayo Clinic are scaling AI-driven discovery, and how Gilead’s latest acquisition strengthens its position in cell therapy for multiple myeloma.
In today’s ACT Brief, we examine how Evinova is scaling AI-driven clinical development through industry collaboration, how the clinical trial project manager role is evolving amid growing complexity, and how FDA scrutiny of compounded GLP-1s could reshape market dynamics.
In today’s ACT Brief, we examine how SCOPE 2026 reinforced the link between speed and strategy, how AI adoption is driving real-world efficiency gains, and how FDA’s evolving evidence standards could reshape approval pathways.
In today’s ACT Brief, we examine how predictive analytics are shaping portfolio decisions, how industry collaboration is scaling digital data standards, and how FDA review of an mRNA flu vaccine candidate is back on track.
In today’s ACT Brief, we examine how AI is enabling continuous trial monitoring and faster site decisions, how provider participation influences recruitment in pragmatic trials, and how leadership restructuring at HHS may shape health policy execution.
In today’s ACT Brief, we examine how AI is shifting from pilot programs into daily development workflows, how a new adoption platform is helping sponsors integrate digital measurement tools, and how global competition and data-driven site selection are reshaping clinical trial activity.
In today’s ACT Brief, we explore how eSource adoption is advancing with AI-enabled validation and interoperability, examine how flexible outsourcing models are helping sponsors balance control and efficiency, and highlight why adaptive, simulation-driven trial design is becoming essential to improving study success.
In today’s ACT Brief, we examine new data on regional variation in clinical trial risk, why patient experience must move from intent to execution, and how digital endpoints are advancing efficiency and regulatory alignment in oncology trials.
In today’s ACT Brief, we cover a new real-world data collaboration aimed at scalable interoperability, how AI fits into modern data capture and quality oversight, and what leaders say must change to move diversity efforts forward in clinical trials.
In today’s ACT Brief, we cover how AI is being deployed to optimize global trial design, why ESG performance is emerging as a core vendor qualification signal, and how sites are becoming more selective as payment practices come under scrutiny.
In today’s ACT Brief, we highlight how purpose-driven efficiency is reshaping clinical development priorities, where leaders see the greatest opportunity for accelerating trial timelines, and how artificial intelligence is already influencing decisions across the R&D lifecycle.
In today’s ACT Brief, we examine how reduced FDA capacity is extending regulatory timelines, why sponsors are rethinking operating models to reduce site burden in 2026, and how the FDA and EMA are aligning around guiding principles for artificial intelligence in drug development.
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 oncology-focused CRO models, and new data showing feasibility and enrollment challenges remain stubborn across global trials.
In today’s ACT Brief, we examine why ESG efforts in clinical development are shifting into vendor oversight, what data and governance barriers still limit broader use of de-identified RWE in submissions, and new Phase II obesity data from Roche as its program moves toward Phase III.
In today’s ACT Brief, we explore why decentralized trial innovations struggle to scale without better change management, where real-world evidence most realistically complements traditional trials, and how efficiency, AI, and platformization are expected to reshape clinical operations in 2026.
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.
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.
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.
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.
