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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.

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.