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 and execut

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 real-world outcomes

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 and enforc

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 treatments across

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 on inspecti

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 how real-w

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 community

Beyond 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 clinical and scien

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 nine European

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 weight-loss

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 gene therapy

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 regulators acros

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 early readines

The 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 Ritch, chi

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 transactional servic

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 AI deploymen

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, and why he

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