Applied Clinical Trials

1:51

ACT Brief: Ibogaine Trial Design Guidance,...

Applied Clinical Trials ·

2026/10/06

In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.

en-us

1:42

ACT Brief: AI Adoption Starting Points, Hierarchical...

Applied Clinical Trials ·

2026/10/05

In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.

en-us

1:52

ACT Brief: Proactive Trial Risk Management, Federal...

Applied Clinical Trials ·

2026/10/02

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 and execution, and FDA approval expanding heart disease therapy to adolescents.

en-us

1:54

ACT Brief: AI as Design Advisor, Autonomous Agent...

Applied Clinical Trials ·

2026/10/01

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 real-world outcomes from switching to oral weight-loss therapy.

en-us

1:40

ACT Brief: Enrollment Feasibility Pressure-Testing,...

Applied Clinical Trials ·

2026/09/30

In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.

en-us

1:51

ACT Brief: Trial Simulations and Protocol Risk, RBQM...

Applied Clinical Trials ·

2026/09/29

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 treatments across hair loss, movement disorder, and bone disease.

en-us

1:52

ACT Brief: AI Expands Endpoint Options, CRO Oversight...

Applied Clinical Trials ·

2026/09/28

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 on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.

en-us

1:55

ACT Brief: Patient-Site Trust Barriers, Rare Disease...

Applied Clinical Trials ·

2026/09/25

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 how real-world data and AI improve enrollment screening accuracy.

en-us

2:07

ACT Brief: Data Provenance and Device Strategy,...

Applied Clinical Trials ·

2026/09/24

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 community care, and why data harmonization is AI's primary bottleneck.

en-us

21:27

Beyond Compliance: Vivalink's Cecilia Xi, PhD, on...

Applied Clinical Trials ·

2026/09/23

In this episode of Beyond Compliance, Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, speaks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about why defensible trial data depends on traceability, platform ownership, and device strategy long after a study ends.

en-us

1:51

ACT Brief: Patient Journey and Study Design,...

Applied Clinical Trials ·

2026/09/23

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 nine European drugmakers are sounding urgent alarms.

en-us

1:38

ACT Brief: Patient-Site Interaction and Technology,...

Applied Clinical Trials ·

2026/09/22

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 weight-loss drug results in competitive comparison.

en-us

1:39

ACT Brief: Patient-Site Trust and AI Role, Platform...

Applied Clinical Trials ·

2026/09/21

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 gene therapy for a rare childhood syndrome.

en-us

1:47

ACT Brief: Patient Voice as Methodology, AI System...

Applied Clinical Trials ·

2026/09/18

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 regulators across three jurisdictions are formalizing patient input requirements.

en-us

1:45

ACT Brief: Expedited IND Pilot Launch, Operating...

Applied Clinical Trials ·

2026/09/17

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 early readiness signals predict trial risk.

en-us

43:33

The Human Side of Clinical Trials: How Measuring...

Applied Clinical Trials ·

2026/09/16

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 Ritch, chief operating officer of ArcheMedX, Inc., explores why training completion metrics like attendance and quiz scores fail to capture true study readiness, and how measuring both competence and confidence can reveal trial risks before enrollment even begins.

en-us

1:52

ACT Brief: Epilepsy Trial Feasibility and Family...

Applied Clinical Trials ·

2026/09/16

In today's ACT Brief, we examine what families with rare epilepsy teach about trial feasibility, how preclinical CRO partnerships are evolving beyond transactional services, and why cortisol dysregulation limits GLP-1 effectiveness in diabetes.

en-us

1:37

ACT Brief: Endpoint Selection and Patient Engagement,...

Applied Clinical Trials ·

2026/09/15

In today's ACT Brief, we examine how shifting patient engagement to endpoint selection improves trial data quality, why execution infrastructure must precede AI deployment, and addressing missing baseline data in real-world oncology research.

en-us

1:51

ACT Brief: Epilepsy Trial Endpoints, Lab...

Applied Clinical Trials ·

2026/09/14

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, and why healthcare needs orchestration rather than more tools.

en-us

1:25

ACT Brief: Patient Voice in Protocol Design,...

Applied Clinical Trials ·

2026/09/11

In today's ACT Brief, we examine genuine patient partnership in trial design, how AI enables informed recruitment while preserving clinician relationships, and moving patient engagement beyond performative gestures.

en-us

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