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 eSource-enabled workfl

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 investment

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 FDA approve

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 immunotherapy to a

The 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 Ritch, chief o

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 development, and why

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 site system

AI 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 process? In

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 rare disease

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 defining next

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 make enroll

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, and a major

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 benefit, and

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