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 moving pat

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 permanent lead

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 and chief

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 differentiator, a

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 concerns shape I

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 integrity revi

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 early-phase capacit

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 ArcheMedX, Inc

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 advancing an

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 accountable teams, a

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 populations, and the

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 China's growing

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 the connected

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 BioSciences, ab

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 assembled

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 development model l

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 reckoning,

ACT Brief: Trial Failures as Administrative Problems, CRO Consolidation for Global Trial Reach, and FDA Approval of First FOP Treatment

In today's ACT Brief, we examine where trial failures actually originate and where AI delivers fastest wins, how CRO consolidation creates global operational scale, and t

ACT Brief: AI Architecture and Model Ownership Due Diligence, FDA Framework for Generative AI Medical Devices, and Heidi Overton Nominated for FDA Commissioner

In today's ACT Brief, we examine why AI architecture and ownership matter more than model sophistication in clinical development, how the FDA proposes to regulate generat

ACT Brief: Phase I Back-Office Automation Priorities, Early Phase Data Interpretation Under Capital Pressure, and Syneos AI Ecosystem Expansion

In today's ACT Brief, we examine which Phase I administrative processes are most ripe for AI automation, how sponsors should balance investor demands for real-time data a