Newsletter | November 13, 2026

11.13.26 -- Fewer Data Silos, Sharper Dose Decisions, Shared Site Intel: What Trial Teams Want Now

CLINICAL DATA MANAGEMENT & ANALYTICS

Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials

Learn from ex-FDA and ELIQUENT consultant Dawn Wydner, Ph.D.., how treating data integrity as an end-to-end clinical information flow issue, rather than a database-only concern, is essential to managing AI-related risk.

PMCF Requirements: Questions On Cost, Device Viability, And AI

PMCF costs are straining device budgets. Discover how AI-assisted review and real-world data from other regions can help you meet EU requirements more efficiently.

Investigator Databank And DQS: Welcoming New Consortium Members

Join the Data Query System consortium to access a comprehensive, collaborative platform that enhances clinical trial feasibility, site selection, and investigator engagement.

Reimagine Quality: Responding To EOL Deadlines

Delay, migrate, or reimagine? Learn how rethinking quality operations around AI can triple team productivity and keep you inspection-ready for the next decade.

Defining Meaningful Anti-Inflammatory Response

Controlled immune challenges link drug exposure to biological effects, helping refine dose selection, test mechanisms and support better decisions before patient trials.

Tech-Enabled FSP Delivery

Struggling with data silos and delayed trial visibility? See how combining AI with smarter data integration helps teams gain real-time visibility without adding headcount.

Accelerating A Schizophrenia Trial While Ensuring Quality

Tight timelines and rising patient targets don't have to derail a trial. See how speed and data quality can work together from enrollment to database lock.

Why More Sponsors Are Taking Control Of Clinical Trial Study Builds

Accelerate study startup and reduce rework by building studies directly in EDC. Discover a more flexible, efficient approach to managing clinical trials and data quality.

Gain Instant Access To HEOR Education With On-Demand Programs

The ISPOR Education Center provides instant access to Health Economics and Outcomes Research (HEOR) education with on-demand programs delivered through a personalized, powerful, and flexible learning platform. Working at their own time and pace, individuals can drive their professional development by growing their knowledge and skills with topical, relevant, and innovative course curricula.

TRIAL MONITORING

Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure

Barnes & Thornburg partner Seth Mailhot provides a primer on risk disclosure and how sponsor companies can prepare for and mitigate issues that might arise.

Tracking Functional Capacity: Neuromuscular Disease Research

This presentation introduces a dual-endpoint approach to monitoring neuromuscular disease progression through two high-centile digital measures.

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