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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.

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.

The agency's guidance addresses the unique challenges of studying compounds like psilocybin and MDMA, from functional unblinding to safety monitoring and abuse potential assessment.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, makes the case that success for CROs in a program-level recruitment model comes down to true partnership, shared data visibility, and a collective commitment to moving patients all the way through the funnel.

In today's ACT Brief, we examine how organizational silos block programmatic recruitment strategies, why regulatory collaboration on selective safety data enables scalability, and FDA approval of an at-home Alzheimer's therapy option.

In this Q&A, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses the collaborative work underway with FDA and CTTI to explore selective safety data collection as a model for de-risking trial design, reducing site and patient burden, and scaling pragmatic trial approaches across the industry.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, identifies organizational silos, siloed budgets, and a study-centric mindset as the biggest barriers to shifting from study-by-study to programmatic recruitment—and explains what it actually takes to map a program that sponsors might not see at first.

In today's ACT Brief, we examine how sponsors can shift to portfolio-level recruitment strategies, why real-time burden sampling captures operational friction before it becomes risk, and FDA approval of a platinum-free bladder cancer combination.

Experience sampling captures real-time signals of site burden and operational friction at the moment they occur, providing earlier and more actionable insight than retrospective assessments and revealing workarounds before they compound into protocol deviations.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, outlines the organizational, budgetary, and technological changes sponsors need to make to move from study-by-study recruitment to a portfolio-level approach that keeps patients engaged across a therapeutic area.

In today's ACT Brief, we examine the FDA's paused real-time complete response letter release policy, why programmatic patient engagement is replacing protocol-centric recruitment, and medical affairs' emerging role in bringing patient perspectives into clinical development.

The agency's complete response letter transparency initiative has been on hold since April following a pharma industry legal challenge, even as the FDA moves to codify the practice through formal rulemaking.

In this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains why the industry's protocol-centric recruitment model has persisted so long and what a shift toward programmatic, relationship-driven patient engagement actually looks like in practice.

The evolving role of medical affairs in connecting patients, physicians, and evidence generation.

In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should be viewed as a configurable continuum rather than binary choice, and a new pegfilgrastim biosimilar completing a major G-CSF portfolio.

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 this video interview, Gaynor Anders, chief delivery officer at Trialbee, explains how the FDA's shift toward single pivotal trials is raising the stakes for sponsors on recruitment quality, feasibility precision, diversity, and retention—and why sponsors now say they get one shot to get it right.