Newsletter | September 5, 2026
AUGUST’S ESSENTIAL EDITORIAL: AI RISK, DESIGN, AND ROI
Agentic AI ROI In Trials: Costs Sponsors Cannot Ignore
By T.G. Prasanna, Beroe, Inc.
Agentic AI is a regulated cost transformation. Assess platform, validation, compliance, and oversight costs before setting a clinical AI strategy.
Clinical AI Validation Fails Without Portability Testing
By John Oncea, chief editor, Clinical Tech Leader
A voice-AI depression-screening study shows why testing across demographic groups is essential before clinical tools are deployed.
Poor eCOA Design Can Undermine Patient Data Quality
Usability testing and cultural adaptation help patients use eCOA successfully, improving engagement, data quality, and trial reliability.
AUGUST’S INDUSTRY WATCH: AI, RWE, AND DATA INTEGRITY
FDA RWE Standards Raise the Stakes For Trial Data Now
By Castor
FDA guidance is raising expectations for RWE. Sponsors need interoperable, audit-ready RWD infrastructure for faster, defensible submissions.
How Data Ownership Prevents Clinical Trial Errors And Rework
By Rich Wzorek and Mark Dickinson, Almac Clinical Technologies
Clear data ownership and tailored reporting reduce manual reconciliation, prevent errors, and keep trial data accurate, traceable, and audit-ready.
Agentic AI Connectors: What Makes Trial Automation Work
By Medable
Learn how modular agents, connectors, and MCP frameworks enable interoperable, scalable automation across clinical development workflows.
AUGUST’S TRIAL TECH TOOLS: DATA, APIS, AND WORKFLOW RELIEF
Eliminate Paper Binders To Accelerate Trial Workflows
Florence Healthcare
Clinical Trial APIs That Connect Data And Workflows
Crucial Data Solutions
Why RTSM Recognition Matters For Clinical Trial Delivery
Endpoint Clinical
