
Metrics & Benchmarks
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FDA Pauses Real-Time Release of Drug Rejection Letters While Working to Formalize Policy

Why Rebuilding Patient Pipelines from Scratch for Every Study Has to Stop

Bringing the Voice of Clinical Practice and Patients into Drug Development

ACT Brief: Single Pivotal Trial Stakes, Configurable FSP Strategy, and G-CSF Biosimilar Portfolio Expansion

Tailoring Your FSP Approach: Why One Model Doesn’t Fit Every Trial

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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.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, explains why scaling pragmatic and decentralized trial approaches, not just piloting them once, is where the real reduction in cost and burden happens.

In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.

Protocol assumptions about patients, visit schedules, timelines, and vendors are rarely tested against operational reality until startup, but early engagement of experienced execution strategists can identify and mitigate feasibility gaps before commitments harden into expensive course corrections.

In this video interview, Rob DiCicco, vice president of portfolio management at TransCelerate Biopharma, breaks down CTTI research showing 50 to 75% reductions in visits and assessments using selective safety data collection, and why mature assets make this approach safe to use.

In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.






















