Applied Clinical Trials

23:40

Beyond Compliance: NetraMark's Joseph Geraci, PhD, on...

Applied Clinical Trials ·

2026/09/09

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 scientific and technical officer at NetraMark, about why explainable AI, not black-box prediction, is needed to reveal clinically meaningful patient subgroups in regulated drug development.

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1:46

ACT Brief: RBQM Multi-Functional Buy-In and E6(R3),...

Applied Clinical Trials ·

2026/09/09

In today's ACT Brief, we examine how regulatory guidance and financial evidence enable RBQM adoption, why site payment performance remains a competitive differentiator, and a collaboration advancing an inhaled approach to cystic fibrosis.

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1:39

ACT Brief: Hidden RBQM Value, Rare Disease Patient...

Applied Clinical Trials ·

2026/09/08

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 IBD treatment decisions despite clinical efficacy.

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1:41

ACT Brief: Time Savings as RBQM Value Driver, FDA...

Applied Clinical Trials ·

2026/09/04

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 review, and how data governance models shape real-world evidence quality.

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1:47

ACT Brief: Human Readiness as Operational Foundation,...

Applied Clinical Trials ·

2026/09/03

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 capacity, and how AI-enabled patient matching is reshaping recruitment economics.

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15:26

Introducing The Human Side of Clinical Trials

Applied Clinical Trials ·

2026/09/02

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., exploring why operational failures in clinical trials often trace back to gaps in human readiness rather than process design alone.

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1:35

ACT Brief: RBQM Financial Value Quantification, Trial...

Applied Clinical Trials ·

2026/09/02

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 mRNA flu vaccine candidate to late-stage testing.

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1:46

ACT Brief: Operating Model Change Before AI,...

Applied Clinical Trials ·

2026/09/01

In today's ACT Brief, we examine why operating model redesign must precede agentic AI deployment, how integrated platforms compress operations toward accountable teams, and BioNTech's decision to terminate a colorectal cancer mRNA trial.

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1:41

ACT Brief: Site Cash Runway and Payment...

Applied Clinical Trials ·

2026/08/31

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 growing role of predictive maintenance in preventing batch losses.

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1:45

ACT Brief: Site Relationships and Payment...

Applied Clinical Trials ·

2026/08/28

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 dominance in early-stage drug discovery.

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1:49

ACT Brief: AI in Invoice Processing, Botanical...

Applied Clinical Trials ·

2026/08/27

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 financial systems reshaping trial operations.

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37:07

Beyond Compliance: AJNA BioSciences' Joel Stanley on...

Applied Clinical Trials ·

2026/08/26

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, about why botanical therapies need pharmaceutical-grade standardization and clinical evidence to earn physician trust and insurance coverage.

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1:58

ACT Brief: Payment Infrastructure and Site Cash,...

Applied Clinical Trials ·

2026/08/26

In today's ACT Brief, we examine why payment inconsistency persists despite industry awareness, why inspection readiness must be built throughout execution not assembled at submission, and FDA approval of the first disease-specific treatment for a rare blood disorder.

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2:06

ACT Brief: Payment Performance as Operational Brand,...

Applied Clinical Trials ·

2026/08/25

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 looks like, and a licensing deal for a next-generation obesity therapy combining Phase I data with preclinical validation.

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1:44

ACT Brief: AI Literacy and Ecosystem Adoption...

Applied Clinical Trials ·

2026/08/24

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, and two major platform collaborations advancing discovery speed.

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1:34

ACT Brief: Trial Failures as Administrative Problems,...

Applied Clinical Trials ·

2026/08/21

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 the first FDA-approved treatment for a rare progressive bone disorder.

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1:41

ACT Brief: AI Architecture and Model Ownership Due...

Applied Clinical Trials ·

2026/08/20

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 generative AI-enabled medical devices, and a new leadership appointment at the agency.

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1:46

ACT Brief: Phase I Back-Office Automation Priorities,...

Applied Clinical Trials ·

2026/08/19

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 against scientific rigor in capital-constrained trials, and a major CRO's expanded artificial intelligence partnerships.

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1:57

ACT Brief: TrialBlazer Timeline Reductions and...

Applied Clinical Trials ·

2026/08/18

In today's ACT Brief, we examine what actually drives the 6- to 12-month timeline reductions envisioned under Operation TrialBlazer, why trial modernization requires structural changes in sponsor-site collaboration, and a major biosimilars commercialization partnership.

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1:43

ACT Brief: Data Standardization Bottleneck in...

Applied Clinical Trials ·

2026/08/17

In today's ACT Brief, we examine the standardization gap that sits between raw data collection and real-time analysis, why regulatory unpredictability is pushing US biotechs to run early trials overseas, and FDA accelerated approval of a new immunomodulatory therapy.

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