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.
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.
In today's ACT Brief, we examine AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling concentrated AI strategy across a global pharmaceutical enterprise.
Eligibility criteria alone rarely predict enrollment, which depends more on trust, hope, and fear, requiring relationship-based community engagement paired with behavioral readiness assessments rather than transactional outreach.
AI-enabled systems medicine could influence which populations are selected for trials, how biomarkers are validated, how products are positioned, how evidence is generated after launch, and how value is demonstrated to payers.
In today's ACT Brief, we examine how selective safety data collection could ease operational burden and address investigator shortages, why site-specific technology limits AI adoption, and how regulatory pressure and patent cliffs are reshaping R&D investment strategy.
In this Q&A, Liz Beatty, co-founder and chief strategy officer at Inato, discusses how real-time patient data is reducing non-enrolling sites, why sponsor-specific technology remains the biggest barrier to adoption, and what a shift toward cross-asset site partnerships could mean for enrollment efficiency.
In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, looks ahead to how simplification built through selective safety data collection could ease broader trial operations and help address a shrinking investigator pool.
In today's ACT Brief, we examine regulatory partnerships debunking pragmatic trial concerns, how ePRO protocols create informal patient exclusions, and why system design—not patient behavior—drives disengagement.
In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, discusses how CTTI tabletop exercises are myth-busting perceived risk and why true progress requires partnership across regulators, sponsors, providers, and patients.
When clinical trial teams screen for "tech-savvy, engaged" participants, they're often running a second, unwritten eligibility criterion that systematically excludes the populations the study drug is actually meant to treat.
