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.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, identifies where the most consequential capability gaps accumulate—from protocol-to-execution bridging to how sponsor oversight roles are structured and staffed.
In today's ACT Brief, we examine how early assumptions govern development outcomes, why single pivotal trials require portfolio recruitment with integrated technology, and how risk frameworks must embed quality into design from the start.
In this Q&A, Gaynor Anders, chief delivery officer at Trialbee, discusses how the FDA's single pivotal trial shift is raising the stakes on patient recruitment, why the study-by-study model has persisted for so long, and what program-level recruitment actually requires from sponsors in terms of infrastructure, data sharing, and organizational change.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, makes the case that the assumptions accumulated at the moment of a product development decision govern everything that follows—and why deferring that work doesn't save time, it just makes it more expensive to fix.
In today's ACT Brief, we examine how outsourcing transfers accountability in sponsor organizations, why biomarker strategy requires understanding tumor biology beyond single targets, and FDA clearance for a novel sciatica treatment.
Phase III oncology setbacks often reflect incomplete biological understanding rather than target failures, but robust biomarker strategy and multi-dimensional patient selection developed early in development can strengthen pivotal trial design and increase success.
In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why the belief that outsourcing execution transfers accountability is the most consequential and least examined gap in how sponsor organizations are structured.
In today's ACT Brief, we examine how programmatic recruitment requires portfolio funding and behavioral readiness integration, why clinical R&D modernization stalls without systems-level thinking, and FDA's traditional approval of a kidney function-preserving therapy.
Clinical R&D modernization stalls through incremental optimization of individual workflows, but meaningful systemic change requires leaders to visualize structural relationships, understand hidden incentives, and identify leverage points that benefit the whole system rather than parts.
As the FDA's single-trial standard raises the cost of recruitment failure and diversity expectations intensify, sponsors are under pressure to move beyond study-by-study outreach toward programmatic, relationship-based approaches that treat patient engagement as a long-term strategic capability rather than a per-study operational task.
In today's ACT Brief, we examine how local-first approaches can redesign clinical trial communication, quantitative evidence on risk-based quality management returns, and FDA approval of an oral cholesterol-lowering therapy.
New peer-reviewed research combining real-world RBQM data with Tufts CSDD benchmarks finds ROI multiples as high as 23x, with time savings identified as the primary driver of financial value.
The traditional global-to-local communication model creates fragmented content through sequential adaptation, but a local-first approach using structured data and AI-orchestrated generation can embed stakeholder terminology and preferences from the start, reducing rework while improving clarity and relevance.
In today's ACT Brief, we examine CRO success through program-level partnership, FDA guidance addressing psychedelic trial design challenges, and approval of a comprehensive cancer pathway inhibitor.
