In this Q&A, Elizabeth Walsh, PMP, ACRP-CP, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, discusses the persistent misconceptions about sponsor accountability, why execution gaps originate long before study startup, and what genuine inspection readiness looks like when it is built in from the outset.
In this video interview, Stella K. Vnook, PhD, CEO of Kaida BioPharma and founder of Aviva Ventures, explains how declining NIH funding, late-stage pharma acquisition strategies, and global operating pressures are forcing sponsors to move faster and more capital-efficiently toward clinical inflection points.
In today's ACT Brief, we examine the $500,000-per-day cost of execution delays and protocol variance at the point of care, why oncology real-world data requires hybrid clinical expertise with technology, and scaling challenges as trial data volumes continue to grow.
Real-world oncology data requires hybrid curation combining clinical expertise with technology to address variability in documentation, missing data, and complex concepts like lines of therapy that are often implicit rather than explicitly recorded in EHRs.
With delayed trials carrying a significant cost burden, poor execution at the point of care is a liability no AI discovery tool can fix.
In today's ACT Brief, we examine how a gradual, win-driven strategy scales real-time monitoring adoption, why consumer wearables need rigorous fit-for-purpose validation, and an FDA committee's favorable vote on Replimune's oncolytic virus combination therapy.
Consumer-grade wearables offer promise for reducing trial burden and improving engagement, but accuracy and reliability vary substantially by device, measurement, and population, requiring rigorous fit-for-purpose validation and careful endpoint selection before integration into regulated research.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, outlines a gradual, win-driven strategy for making real-time monitoring stick—starting in early phases and building toward pivotal trials with the right technology partners and a network effect that scales.
In today's ACT Brief, we examine why real-time monitoring scales only through coordinated ecosystem efforts, how organizational failures not models explain weak AI results, and FDA's advisory panel peptide compounding decision.
As agentic AI, automated data harmonization, and real-time monitoring reshape clinical development, the organizations seeing meaningful results are those that have invested in unified data infrastructure and disciplined governance rather than cycling through pilots without the foundation to scale them.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, makes the case that scaling real-time data review requires an ecosystem approach—bringing regulators, sponsors, CROs, and technology vendors together in a shared learning environment rather than letting progress remain siloed.
As clinical development grows increasingly complex and talent markets remain constrained, sponsors must evolve beyond binary outsourcing decisions to embrace a configurable functional service provider continuum that enhances operational optionality without requiring wholesale restructuring.
In today's ACT Brief, we examine how sustainability is shifting from compliance to a procurement driver, what infrastructure gaps remain in FDA's real-time pilot model, and regulatory guidance targeting unnecessarily restrictive cancer trial criteria.
New documents targeting performance status, washout periods, and laboratory value thresholds aim to close the gap between patients willing to participate in oncology trials and those who actually enroll.
In this pilot episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Paulo Limgenco, VP of business operations and ESG strategy lead at YPrime, about how sustainability is shifting from a compliance checkbox to a factor that shapes vendor selection, client trust, and long-term business value.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, explains why the FDA's real-time clinical trial pilot was promising but not yet scale ready—and what technology infrastructure needs to be in place for the model to work broadly.
In today's ACT Brief, we examine how data standardization must precede real-time monitoring deployment, why contracts cannot transfer sponsor oversight responsibility, and a strategic acquisition broadening immunology development.
Clinical development operates as an integrated system where dependencies persist across phases and vendors, but treating contracts as execution handoffs creates invisible oversight gaps that surface later as vendor performance problems, timeline slips, or inspection findings.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, breaks down the standardization and mapping work that must happen before streaming data can be analyzed meaningfully—and how AI is beginning to make that process fast enough to enable real-time monitoring at scale.
In today's ACT Brief, we examine the data collection-to-analysis gap undermining continuous trial monitoring, why AI agents require foundational workflow infrastructure, and FDA approval of a novel ADHD treatment.
AI agents operate only within workflows, but most organizations lack unified workflow management systems, making it difficult to identify where agents should be deployed or ensure they integrate effectively across connected business processes in clinical research.
In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, explains why the gap between data collection and analysis-ready data undermines the promise of continuous trial monitoring and what it will take to close it.
In today's ACT Brief, we examine how inspection readiness must accumulate rather than assemble, why AI initiatives stall without disciplined governance, and what US clinical trials need beyond isolated initiatives.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, describes what it means to accumulate inspection readiness rather than assemble it—and why the story regulators reconstruct is determined long before an inspection is announced.
AI churn—repeatedly restarting initiatives before scaling them—stems from organizational execution gaps rather than technology limitations, but agentic AI amplifies these gaps by requiring connected systems, trustworthy data, and disciplined governance from the start.
In today's ACT Brief, we examine why execution failures originate upstream despite surfacing downstream, how European health data frameworks transform CRO roles, and why US trial competitiveness varies by development phase.
The European Health Data Space reshapes CRO operations by transitioning them from data custodians to regulated users accessing data within secure, auditable environments, enabling cross-border research but requiring substantial investment in compliance, standardization, and methodological rigor.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why execution failures surface where they're visible but originate where conditions were set—and why clinical operations leaders too often inherit problems they had no hand in creating.
In today's ACT Brief, we examine where sponsor capability gaps accumulate in protocol execution, how partnerships are embedding trials in community settings, and whether Project Trialblazer can compete with faster international pathways.
Bayer and Henry Ford Health announce a strategic research alliance, while Massive Bio and FOMAT launch an AI-driven oncology prescreening pilot—both targeting barriers that keep eligible patients from reaching clinical trials.
