Newsletter | January 27, 2026

01.27.26 -- Navigating FDA's New AI Systems

CLINICAL TRIAL TECHNOLOGY

Navigating FDA's New AI Systems: Practical Tips For Regulatory Success

AI-assisted reviews are changing FDA submissions. In part two of this series, discover how sponsors can address and even preempt regulatory and legal concerns.

Why Real-Time eCOA Data Matters More Than Ever

Real-time eCOA data enables faster eligibility decisions, proactive issue alerts, and streamlined operations by unifying data, improving precision, responsiveness, and trial execution efficiency.

EHR-To-EDC Success In A Complex, Adaptive Platform Trial

I-SPY 2, one of the longest-running adaptive platform trials in oncology, is revolutionizing breast cancer research through a dynamic, data-driven approach to evaluating novel therapies.

5 Key Benefits Of Digital Biomarkers

Digital biomarkers enable continuous and objective data collection, significantly reducing the variability and subjectivity inherent in traditional assessments.

Replace Disparate Source Templates With A Unified Framework

Central eSource transforms the conduct of clinical trials by replacing disparate, site-specific source templates with a unified, sponsor-designed framework.

Auto Generate Documentation

Unlock seamless software development with IQVIA’s eCOA, which automates screenshots, validation documentation, and audit trails, ensuring real-time updates, easy exports, and full traceability.

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