Shows / Applied Clinical Trials
Episodes
Applied Clinical TrialsACT Brief: APAC Trial Advantages, Learning From Setbacks, and Sunharbo Stroke Prevention Approval
In today’s ACT Brief, we examine why APAC is attractive for global Phase III programs, how clinical research professionals can turn a failed pivotal trial into…
- Applied Clinical Trials
ACT Brief: China’s Startup Timelines, AI-Drafted Clinical Study Reports, and Bimzelx Psoriatic Arthritis Data
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…
- Applied Clinical Trials
ACT Brief: APAC Inspection Findings, RBQM Key Risk Indicators, and Head and Neck Cancer Approval
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…
- Applied Clinical Trials
ACT Brief: Asia Pacific Site Perceptions, Community Access Gap, and VeonGen Gene Therapy Alignment
In today’s ACT Brief, we examine why outdated views of Asia Pacific trial sites persist, how community access gaps reflect both patient costs and site…
- Applied Clinical Trials
ACT Brief: Capturing Trial Friction, AI Matching Model Comparisons, and Boehringer’s Oncology Deal
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…
Applied Clinical TrialsThe Human Side of Clinical Trials: Before Burden Becomes Risk, Capturing Friction in Real Time
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…
- Applied Clinical Trials
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…
- Applied Clinical Trials
ACT Brief: Embedding AI Across Operations, Faster Trial Decisions, and Voceryq Approval
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…
- Applied Clinical Trials
ACT Brief: Community Research Policy Needs, Walmart Trial Centers, and Psoriatic Arthritis Approval
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…
- Applied Clinical Trials
ACT Brief: Community Research Access, Trustworthy AI Assistants, and Individualized Gene Editing Guidance
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…
- Applied Clinical Trials
ACT Brief: Community Trial Access Technology, RBQM Infrastructure, and Digital Clone Use Cases
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…
- Applied Clinical Trials
ACT Brief: Legacy Trial Workflows, Medical Writing Talent Gaps, and Post-Exposure COVID Prevention
In today’s ACT Brief, we examine how legacy workflows pull community clinics away from patient care, why medical writing capacity depends on training rather…
- Applied Clinical Trials
ACT Brief: Community Trial Cost Barriers, Measuring What Matters, and Prostate Cancer Approval
In today’s ACT Brief, we examine how cost barriers and site infrastructure limit participation in community trials, why endpoints should reflect what patients…
- Applied Clinical Trials
ACT Brief: Orchestrated AI Clinical Environments, eSource Coordinator Satisfaction, and Faster Clinical Trials Act
In today’s ACT Brief, we examine why the future of AI in trials is a trusted orchestration system rather than a single model, how coordinators rate…
- Applied Clinical Trials
ACT Brief: Applied Clinical Trials at 2026 SCRS Global Site Solutions Summit
In today’s ACT Brief, we examine how sites can avoid both fear-driven and overly aggressive AI adoption, why community-based research needs sustained financial…
- Applied Clinical Trials
ACT Brief: AI Operating Models, Oncology Evidence Trust, and Thyroid Eye Disease Approval
In today’s ACT Brief, we examine how AI is moving into continuous clinical operating models, how trust is built into oncology real-world evidence, and how the…
- Applied Clinical Trials
ACT Brief: Who Sets Trial Endpoints, Human-Centered Trial Execution, and Bladder Cancer Approval Expansion
In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an…
Applied Clinical TrialsThe Human Side of Clinical Trials: Why Fuzzy Mental Models Undermine Clinical Trial Execution
In Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly…
- Applied Clinical Trials
ACT Brief: EHR-to-EDC Connectivity, FDA’s Rare Disease Framework, and Barriers to Oncology RWE
In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug…
- Applied Clinical Trials
ACT Brief: Design Drivers of Trial Representation, eSource-to-EDC Data Automation, and Roche's ALK7 Obesity License
In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from…
Applied Clinical TrialsAI and Patient Recruitment: Can Predictive Promise Drive True Transformation?
Can artificial intelligence help turn what many believe is clinical development’s biggest variable — and most prevailing bottleneck — into a more predictable…
- Applied Clinical Trials
ACT Brief: RBQM Analysis Frequency, Building Trust in Oncology Data, and Rare Pediatric PRV Monetization
In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how…
- Applied Clinical Trials
ACT Brief: AI and Protocol Design, Site Training Readiness, and GLP-1 Unmet Needs
In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities…
- Applied Clinical Trials
ACT Brief: FDA Transparency Roadmap, Radiopharmaceutical Trial Operations, and AI-Powered Enrollment Prediction
In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can…
- Applied Clinical Trials
ACT Brief: Ibogaine Trial Design Guidance, Outsourcing Model Oversight Gaps, and Kidney Disease Partnership
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure…
- Applied Clinical Trials
ACT Brief: AI Adoption Starting Points, Hierarchical Endpoints and Patient Priorities, and Early-Stage Program Termination
In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment…
- Applied Clinical Trials
ACT Brief: Proactive Trial Risk Management, Federal Infrastructure Modernization, Pediatric Heart Disease Treatment
In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design…
- Applied Clinical Trials
ACT Brief: AI as Design Advisor, Autonomous Agent Governance, Oral Weight-Loss Therapy Switch
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and…
- Applied Clinical Trials
ACT Brief: Enrollment Feasibility Pressure-Testing, RWE Infrastructure Gaps, and Peptide Rulemaking Standstill
In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking…
- Applied Clinical Trials
ACT Brief: Trial Simulations and Protocol Risk, RBQM Financial Value Quantified, and Three Drug Approvals
In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved…
- Applied Clinical Trials
ACT Brief: AI Expands Endpoint Options, CRO Oversight Documentation, and Kidney Cancer Approval
In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails…
- Applied Clinical Trials
ACT Brief: Patient-Site Trust Barriers, Rare Disease Evidence Without Registry, and RWD Enrollment Accuracy
In today's ACT Brief, we examine what patient-site relationships need beyond easier technology, how to build defensible rare disease evidence from scratch, and…
- Applied Clinical Trials
ACT Brief: Data Provenance and Device Strategy, Cell-Gene Therapy Site Readiness, and Data Harmonization Bottleneck
In today's ACT Brief, we examine why defensible trial data depends on traceability and platform ownership, what CGT site readiness requires as therapy moves to…
Applied Clinical TrialsBeyond Compliance: Vivalink's Cecilia Xi, PhD, on Data Provenance and Sustainable Device Strategy in Clinical Trials
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of…
- Applied Clinical Trials
ACT Brief: Patient Journey and Study Design, Decentralization's True Cost, and Europe's Pharma Competitiveness Crisis
In today's ACT Brief, we examine understanding the patient journey from end to end, whether decentralization reduces site burden or just shifts it, and why…
- Applied Clinical Trials
ACT Brief: Patient-Site Interaction and Technology, AI Pilot Success Requires Discipline, and CagriSema Beats Lilly Drug
In today's ACT Brief, we examine technology's real role in patient-site collaboration, why AI pilot failures stem from organization not innovation, and Novo's…
- Applied Clinical Trials
ACT Brief: Patient-Site Trust and AI Role, Platform Approach to Scale, Gene Therapy for Pediatric Disease
In today's ACT Brief, we examine what patient-site relationships need most at DPHARM, how platform-based AI scales across workflows, and FDA's approval of a…
- Applied Clinical Trials
ACT Brief: Patient Voice as Methodology, AI System Bottlenecks, Regulatory Convergence on Patient Input
In today's ACT Brief, we examine what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how…
- Applied Clinical Trials
ACT Brief: Expedited IND Pilot Launch, Operating Model Importance, and Readiness Prediction
In today's ACT Brief, we examine FDA's expedited pathway for first-in-human trials, why operating model design matters more than sourcing strategy, and how…
Applied Clinical TrialsThe Human Side of Clinical Trials: How Measuring Readiness at Training Predicts Trial Risk Before It Shows Up in the Data
This episode of The Human Side of Clinical Trials, hosted by Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly…
- Applied Clinical Trials
ACT Brief: Epilepsy Trial Feasibility and Family Realities, CRO Partnerships and Strategic Value, and Cortisol and GLP-1 Response
In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond…
- Applied Clinical Trials
ACT Brief: Endpoint Selection and Patient Engagement, Execution Infrastructure Before AI, and Real-World Data Quality Gaps
In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede…
- Applied Clinical Trials
ACT Brief: Epilepsy Trial Endpoints, Lab Orchestration and Scientific Intent, and Systems Over Point Solutions
In today's ACT Brief, we examine why seizure reduction misses what families want from epilepsy trials, how lab coordination requires connecting data to intent…
- Applied Clinical Trials
ACT Brief: Patient Voice in Protocol Design, AI-Informed Recruitment Workflows, and Engagement Maturity Beyond Performative
In today's ACT Brief, we examine genuine patient partnership in trial design, how AI enables informed recruitment while preserving clinician relationships, and…
- Applied Clinical Trials
ACT Brief: Explainable AI for Patient Subgroups, Participant Understanding and Engagement, and FDA Leadership Stabilization
In today's ACT Brief, we examine why black-box AI fails in clinical trials, how participant understanding drives engagement more than gamification, and FDA…
- Applied Clinical Trials
Beyond Compliance: NetraMark's Joseph Geraci, PhD, on Making AI-Driven Patient Subgroups Explainable
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joseph Geraci, PhD, co-founder…
- Applied Clinical Trials
ACT Brief: RBQM Multi-Functional Buy-In and E6(R3), Site Payment Performance and Cash Runway, and Inhaled Therapy for Cystic Fibrosis
In today's ACT Brief, we examine how regulatory guidance and financial evidence enable RBQM adoption, why site payment performance remains a competitive…
- Applied Clinical Trials
ACT Brief: Hidden RBQM Value, Rare Disease Patient Partnership, and Safety Perception in IBD
In today's ACT Brief, we examine value hidden in the RBQM financial model, why rare disease research leads on genuine patient partnership, and how safety…
- Applied Clinical Trials
ACT Brief: Time Savings as RBQM Value Driver, FDA Tightens Foreign Trial Oversight, and Trusted Research Environments Versus Flat Files
In today's ACT Brief, we examine why time savings dominates the financial case for RBQM investment, how the FDA is strengthening inspection access and data…
- Applied Clinical Trials
ACT Brief: Human Readiness as Operational Foundation, Early Phase Capacity Consolidation, and AI-Driven Patient Matching Scale
In today's ACT Brief, we examine why many trial failures trace to human readiness gaps rather than process design alone, how CRO consolidation expands…
- Applied Clinical Trials
Introducing The Human Side of Clinical Trials
This pilot episode of The Human Side of Clinical Trials introduces a framework from Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of…
- Applied Clinical Trials
ACT Brief: RBQM Financial Value Quantification, Trial Budget Cost Visibility Gap, and GSK mRNA Flu Vaccine Phase III
In today's ACT Brief, we examine how eNPV modeling and real-world data finally put numbers on RBQM value, why static budgeting masks true site costs, and GSK…
- Applied Clinical Trials
ACT Brief: Operating Model Change Before AI, Workforce Compression Through Integration, and Cevumeran Trial Termination
In today's ACT Brief, we examine why operating model redesign must precede agentic AI deployment, how integrated platforms compress operations toward…
- Applied Clinical Trials
ACT Brief: Site Cash Runway and Payment Infrastructure Priority, Biomarker Cut-Off Selection and Disparities, and Batch Failure Prevention Systems
In today's ACT Brief, we examine why 80% of sites operate on minimal cash reserves, how biomarker-informed enrollment risks excluding viable patient…
- Applied Clinical Trials
ACT Brief: Site Relationships and Payment Reliability, AI Adoption Without Governance Risk, and China's Biotech Innovation Rise
In today's ACT Brief, we examine how unpredictable payments damage site retention, why rapid AI deployment without validation creates regulatory risk, and…
- Applied Clinical Trials
ACT Brief: AI in Invoice Processing, Botanical Medicines and FDA Pathways, and Connected Trial Finance Systems
In today's ACT Brief, we examine where agentic AI delivers immediate wins in site payments, how botanical therapies can earn pharmaceutical credibility, and…
- Applied Clinical Trials
Beyond Compliance: AJNA BioSciences' Joel Stanley on Bringing Botanical Medicine Through the FDA Pathway
In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Joel Stanley, CEO of AJNA…
- Applied Clinical Trials
ACT Brief: Payment Infrastructure and Site Cash, Inspection Readiness Throughout Execution, and First Hemolytic Anemia Therapy
In today's ACT Brief, we examine why payment inconsistency persists despite industry awareness, why inspection readiness must be built throughout execution not…
- Applied Clinical Trials
ACT Brief: Payment Performance as Operational Brand, Speed and Discipline in Biotech Development Strategy, and Non-GLP-1 Obesity Candidate Licensing
In today's ACT Brief, we examine how payment reliability has become a competitive differentiator at high-performing sites, what a truly strategic lean…
- Applied Clinical Trials
ACT Brief: AI Literacy and Ecosystem Adoption Requirements, CRO Operating Models Under Agentic AI Pressure, and Platform Collaborations in Vaccine and Antibody Discovery
In today's ACT Brief, we examine the three conditions required for AI-driven trial acceleration to work at scale, why agentic AI will force CRO operating model…