Latest News

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.

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.