
Metrics & Benchmarks
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How China Cut Its Phase III Startup Timeline and What Drove the Change

ACT Brief: APAC Inspection Findings, RBQM Key Risk Indicators, and Head and Neck Cancer Approval

What FDA Inspections Reveal About the Quality of APAC Clinical Trial Sites

ACT Brief: Asia Pacific Site Perceptions, Community Access Gap, and VeonGen Gene Therapy Alignment

The 10 Most Powerful Study KRIs in RBQM and GCP Issues They Can Prevent

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In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how regulatory reform and inspection data contradict the view that APAC sites are slower or lower quality, and why sponsors need to update their assumptions.

In this Q&A, Kent Thoelke, CEO of Paradigm Health, discusses why participation gaps in community and rural settings come down to both patient cost barriers and site infrastructure, how legacy workflows weigh on community clinics, and what policy and technology changes it would take to make clinical research a real care option for more patients.

In today’s ACT Brief, we examine how capturing friction in real time can reveal site burden, how OpenAI and Mistral compare on clinical trial matching, and how Boehringer Ingelheim is licensing early-stage oncology programs from SBP Group.

Mistral and OpenAI produced identical overall eligibility labels across 200 synthetic patient-study assessments, with criterion-level disagreements concentrated in inclusion criteria where models switch between “Uncertain” and “Not included” when records lack sufficient evidence, so model choice should be driven by deployment architecture, control, and cost rather than assumed interchangeability.

In Episode 4 of The Human Side of Clinical Trials, host Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., speaks with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about how capturing friction closer to the moment it happens can reveal unclear instructions, technology friction, and workarounds that retrospective surveys and debriefs tend to miss.

ACT Brief: Community Research Financing Gaps, Neuroscience Endpoint Data, and Teva’s Biosimilar Deal
In today’s ACT Brief, we examine why community research needs lasting financing and infrastructure, how electronic outcome tools can strengthen neuroscience endpoints, and how Teva is licensing two biosimilars from Samsung Bioepis.

Neuroscience trials struggle to show benefit because symptoms are subjective and variable, and eCOA strengthens dossiers by standardizing ClinRO administration, capturing outcomes in real time to reduce recall bias, and adding patient and caregiver perspectives that clinician scales miss.

Community participation gaps look less like a question of patient willingness and more like a financing and infrastructure problem that no single bill has yet solved.

In today’s ACT Brief, we examine what changes when AI is embedded across clinical operations, why faster trial data isn’t yet producing faster decisions, and how FDA granted accelerated approval to a therapy for a rare airway disease.

Data capture is no longer the bottleneck, and whether the lag between a signal and a decision shrinks depends on signal design, AI governance, and vendor orchestration.

In this Q&A, Rajneesh Patil, global head of AI, digital, and innovation in clinical development at Syneos Health, discusses what changes when AI is embedded across protocol strategy, data infrastructure, and workflow tools at once, where governance frameworks tend to fall short, and why CROs must orchestrate AI ecosystems rather than simply aggregate them.

In today’s ACT Brief, we examine what policy changes would help community and rural institutions join research, how Walmart is expanding clinical trial centers into three more states, and how FDA approved Ilumya for adults with active psoriatic arthritis.

The planned sites in Livonia, Las Vegas, and San Antonio would expand a partnership that places clinical research and health screenings inside Walmart stores.

In this video interview, Kent Thoelke, CEO of Paradigm Health, calls for safe harbor protections, CMS reimbursement safeguards, and funding mechanisms modeled on EHR meaningful use to help community and rural institutions participate in research on par with academic centers.

In today’s ACT Brief, we examine why community and rural patients lack access to research as a care option, what makes AI assistants trustworthy in regulated trials, and how FDA draft guidance could let gene editing therapies cover patient-specific variants.























