
Metrics & Benchmarks
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You've Been Spending Recruitment Money at the Wrong End of the Funnel

The Risks That Matter Most for Early-Stage and Rare Disease Programs Right Now

ACT Brief: NIH Funding Reshaping Development Strategy, Business Decision Setting Execution Course, and Complex Modality Platform Gaps

Why Execution Strategy Begins at the Business Decision: Q&A with Elizabeth Walsh, Walsh Clinical Advisory

How the Funding Trifecta Is Reshaping Clinical Development Priorities

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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.






















