Applied Clinical Trials Online articleshttps://www.appliedclinicaltrialsonline.com/newsApplied Clinical Trials Online articles© 2026 MJH Life Sciences™ and Applied Clinical Trials Online. All rights reserved.Tue, 10 Nov 2026 14:30:26 +00005en-us14447https://www.appliedclinicaltrialsonline.com/newshttps://www.appliedclinicaltrialsonline.com/logo.webphttps://www.appliedclinicaltrialsonline.com/view/large-pharma-apac-smaller-biotechs-learninghttps://www.appliedclinicaltrialsonline.com/view/large-pharma-apac-smaller-biotechs-learning<![CDATA[In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, outlines why faster recruitment, local data requirements for registration, and lower costs make APAC attractive for global Phase III programs.]]>Tue, 10 Nov 2026 12:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/china-startup-timelines-ai-drafted-clinical-study-reports-bimzelx-psoriatic-arthritis-datahttps://www.appliedclinicaltrialsonline.com/view/china-startup-timelines-ai-drafted-clinical-study-reports-bimzelx-psoriatic-arthritis-data<![CDATA[In today’s ACT Brief, we examine how China’s trial startup timelines compare with those in the US and Europe, whether AI-drafted clinical study reports speed drug development, and how Bimzelx compared with Skyrizi in psoriatic arthritis.]]>Tue, 10 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/ai-draft-csr-faster-drug-developmenthttps://www.appliedclinicaltrialsonline.com/view/ai-draft-csr-faster-drug-development<![CDATA[AI can draft a CSR in minutes, but the report only reflects evidence that has already converged, so faster drafting shifts the bottleneck to upstream reconciliation, database-lock readiness, and human accountability rather than shortening the trial itself.]]>Mon, 09 Nov 2026 19:30:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/how-china-cut-phase-startup-timeline-drove-changehttps://www.appliedclinicaltrialsonline.com/view/how-china-cut-phase-startup-timeline-drove-change<![CDATA[In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, details how NMPA reforms, parallel reviews, and expanded reviewer capacity brought China’s startup timelines in line with the US and Europe, and could shorten them further.]]>Mon, 09 Nov 2026 12:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/apac-inspection-findings-rbqm-key-risk-indicators-head-neck-cancer-approvalhttps://www.appliedclinicaltrialsonline.com/view/apac-inspection-findings-rbqm-key-risk-indicators-head-neck-cancer-approval<![CDATA[In today’s ACT Brief, we examine why APAC inspection findings mirror those in the US and Europe, how key risk indicators should be read together, and how FDA granted accelerated approval to a subcutaneous antibody therapy for recurrent head and neck cancer.]]>Mon, 09 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/fda-inspections-reveal-quality-apac-clinical-trial-siteshttps://www.appliedclinicaltrialsonline.com/view/fda-inspections-reveal-quality-apac-clinical-trial-sites<![CDATA[In this video interview, James Cheong, senior vice president of Asia Pacific at Precision for Medicine, explains how FDA inspection findings at APAC sites compare with those in the US and Europe, and why the common issues, such as informed consent versioning, are not unique to the region.]]>Fri, 06 Nov 2026 12:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/asia-pacific-site-perceptions-community-access-gap-veongen-gene-therapy-alignmenthttps://www.appliedclinicaltrialsonline.com/view/asia-pacific-site-perceptions-community-access-gap-veongen-gene-therapy-alignment<![CDATA[In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site infrastructure, and how VeonGen has aligned with the FDA on a pivotal gene therapy trial design.]]>Fri, 06 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/powerful-study-kris-rbqm-gcp-issueshttps://www.appliedclinicaltrialsonline.com/view/powerful-study-kris-rbqm-gcp-issues<![CDATA[Risk-based quality management depends on knowing what to monitor and on interpreting what the signals mean.]]>Fri, 06 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/why-outdated-perceptions-apac-clinical-trial-sites-persist-among-smaller-biotechshttps://www.appliedclinicaltrialsonline.com/view/why-outdated-perceptions-apac-clinical-trial-sites-persist-among-smaller-biotechs<![CDATA[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.]]>Thu, 05 Nov 2026 19:54:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/closing-community-access-gap-kent-thoelke-paradigm-healthhttps://www.appliedclinicaltrialsonline.com/view/closing-community-access-gap-kent-thoelke-paradigm-health<![CDATA[In this Q&amp;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.]]>Thu, 05 Nov 2026 17:04:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/capturing-trial-friction-ai-matching-model-comparisons-boehringer-oncology-dealhttps://www.appliedclinicaltrialsonline.com/view/capturing-trial-friction-ai-matching-model-comparisons-boehringer-oncology-deal<![CDATA[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.]]>Thu, 05 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/de-risking-fih-integrated-strategies-for-rapid-proof-of-concept-sept-2026https://www.appliedclinicaltrialsonline.com/view/de-risking-fih-integrated-strategies-for-rapid-proof-of-concept-sept-2026<![CDATA[First-in-human studies are often where promising programs encounter delays, uncertainty, and increased risk. This whitepaper examines strategies to de-risk early clinical development through integrated trial design, CMC planning, and streamlined execution, helping sponsors generate proof-of-concept data faster and make more confident development decisions.]]>Wed, 04 Nov 2026 17:12:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/quotient-sciences-first-in-human-to-proof-of-concept-studieshttps://www.appliedclinicaltrialsonline.com/view/quotient-sciences-first-in-human-to-proof-of-concept-studies<![CDATA[Early-phase drug development often stalls when development, manufacturing, and clinical activities operate independently. Learn how an integrated FIH-to-POC model can help address common bottlenecks, improve program continuity, and generate the data needed to make confident development decisions.]]>Wed, 04 Nov 2026 17:12:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/comparing-openai-mistral-clinical-trial-matchinghttps://www.appliedclinicaltrialsonline.com/view/comparing-openai-mistral-clinical-trial-matching<![CDATA[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.]]>Wed, 04 Nov 2026 15:58:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/human-side-clinical-trials-before-burden-becomes-risk-capturing-friction-real-timehttps://www.appliedclinicaltrialsonline.com/view/human-side-clinical-trials-before-burden-becomes-risk-capturing-friction-real-time<![CDATA[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.]]>Wed, 04 Nov 2026 14:28:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/community-research-financing-gaps-neuroscience-endpoint-data-teva-biosimilar-dealhttps://www.appliedclinicaltrialsonline.com/view/community-research-financing-gaps-neuroscience-endpoint-data-teva-biosimilar-deal<![CDATA[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.]]>Wed, 04 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/how-to-recruit-specialty-volunteer-populations-for-eary-phase-clinical-research-5-things-to-ask-when-choosing-a-cro-partner-sept-2026https://www.appliedclinicaltrialsonline.com/view/how-to-recruit-specialty-volunteer-populations-for-eary-phase-clinical-research-5-things-to-ask-when-choosing-a-cro-partner-sept-2026<![CDATA[Recruiting specialty volunteer populations can be one of the biggest challenges in early-phase clinical development, impacting timelines, costs, and data quality. This article outlines five key questions to ask when evaluating a CRO partner, helping sponsors identify recruitment capabilities that support successful study execution.]]>Wed, 04 Nov 2026 05:12:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/complexity-endpoint-meaningfulness-addressing-key-neuroscience-trial-challenges-ecoahttps://www.appliedclinicaltrialsonline.com/view/complexity-endpoint-meaningfulness-addressing-key-neuroscience-trial-challenges-ecoa<![CDATA[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.]]>Tue, 03 Nov 2026 20:37:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/beyond-modernization-act-community-research-infrastructure-permanenthttps://www.appliedclinicaltrialsonline.com/view/beyond-modernization-act-community-research-infrastructure-permanent<![CDATA[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.]]>Tue, 03 Nov 2026 18:57:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/embedding-ai-across-operations-faster-trial-decisions-voceryq-approvalhttps://www.appliedclinicaltrialsonline.com/view/embedding-ai-across-operations-faster-trial-decisions-voceryq-approval<![CDATA[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.]]>Tue, 03 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/signal-action-why-faster-trial-data-producing-faster-decisionshttps://www.appliedclinicaltrialsonline.com/view/signal-action-why-faster-trial-data-producing-faster-decisions<![CDATA[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.]]>Mon, 02 Nov 2026 16:34:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/embedding-ai-across-clinical-operating-model-rajneesh-patil-syneos-healthhttps://www.appliedclinicaltrialsonline.com/view/embedding-ai-across-clinical-operating-model-rajneesh-patil-syneos-health<![CDATA[In this Q&amp;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.]]>Mon, 02 Nov 2026 14:33:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/community-research-policy-needs-walmart-trial-centers-psoriatic-arthritis-approvalhttps://www.appliedclinicaltrialsonline.com/view/community-research-policy-needs-walmart-trial-centers-psoriatic-arthritis-approval<![CDATA[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.]]>Mon, 02 Nov 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/walmart-care-access-clinical-trial-centers-michigan-nevada-texashttps://www.appliedclinicaltrialsonline.com/view/walmart-care-access-clinical-trial-centers-michigan-nevada-texas<![CDATA[The planned sites in Livonia, Las Vegas, and San Antonio would expand a partnership that places clinical research and health screenings inside Walmart stores.]]>Fri, 30 Oct 2026 14:31:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/needs-happen-beyond-clinical-trial-modernization-acthttps://www.appliedclinicaltrialsonline.com/view/needs-happen-beyond-clinical-trial-modernization-act<![CDATA[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.]]>Fri, 30 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/community-research-access-trustworthy-ai-assistants-individualized-gene-editing-guidancehttps://www.appliedclinicaltrialsonline.com/view/community-research-access-trustworthy-ai-assistants-individualized-gene-editing-guidance<![CDATA[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.]]>Fri, 30 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/building-ai-assistants-clinical-trial-teams-trust-ek-koh-suvodahttps://www.appliedclinicaltrialsonline.com/view/building-ai-assistants-clinical-trial-teams-trust-ek-koh-suvoda<![CDATA[In this Q&amp;A, E.K. Koh, chief product officer at Suvoda, discusses what separates a trustworthy AI assistant from one that adds risk, why curated clinical knowledge matters more than general-purpose flexibility, and what safeguards must be in place when assistants move from answering questions to taking actions in clinical trial systems.]]>Thu, 29 Oct 2026 16:06:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/how-embedding-research-routine-community-care-accesshttps://www.appliedclinicaltrialsonline.com/view/how-embedding-research-routine-community-care-access<![CDATA[In this video interview, Kent Thoelke, CEO of Paradigm Health, explains why patients in community and rural settings too often lack access to clinical research as a care option, and how closing that gap could improve outcomes and lower long-term costs.]]>Thu, 29 Oct 2026 11:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/community-trial-access-technology-rbqm-infrastructure-digital-clone-use-caseshttps://www.appliedclinicaltrialsonline.com/view/community-trial-access-technology-rbqm-infrastructure-digital-clone-use-cases<![CDATA[In today’s ACT Brief, we examine why anti-kickback guidance and EHR-integrated trial matching must work together in community settings, why real-time trials depend on mature risk-based quality management, and how pharma is applying digital clones to predict outcomes.]]>Thu, 29 Oct 2026 10:00:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articleshttps://www.appliedclinicaltrialsonline.com/view/real-time-continuous-trials-risk-based-quality-management-why-rbqm-infrastructure-rtcthttps://www.appliedclinicaltrialsonline.com/view/real-time-continuous-trials-risk-based-quality-management-why-rbqm-infrastructure-rtct<![CDATA[The FDA’s RTCT initiative transmits predefined, clinically meaningful signals to regulators during active trials, so its value depends entirely on the maturity of sponsors’ upstream RBQM signal intelligence, KRIs, QTLs, and root-cause context, rather than on data speed.]]>Wed, 28 Oct 2026 18:16:00 GMTApplied Clinical Trials OnlineusApplied Clinical Trials Online Articles