Newsletter | October 23, 2026

10.23.26 -- How One Sponsor Rescued A Trial Mid-Study — Plus 6 Steps To AI-Ready Data

TRIAL MONITORING

Get Ready For Regulators With This Speed-Quality-Compliance Framework

Guest Column | By Sapna Rani, Beroe Inc., and Shaun Hastings

Part two of a two-part series, experts Sapna Rani and Shaun Hastings offer a five-part framework to balance speed, quality, and compliance amid evolving clinical trial regulations.

More Than A Copilot: Agentic Clinical Monitoring In Action

Video | Medable

Clinical monitoring is one of the most resource-intensive and costly parts of a trial, but it’s also one of the biggest opportunities for transformation.

CLINICAL DATA MANAGEMENT & ANALYTICS

When One Clinical Trial Leads To Rethinking Them All

From The Editor | By Dan Schell, Chief Editor, Clinical Leader

A chance observation during the COVID-19 pandemic led physician-scientist Dan Nicolau to question one of clinical research's oldest assumptions. Hear about the trial that changed Nicolau's perspective and why he believes continuous trial analytics could reshape the future of clinical development.

Stabilizing A Biotech Sponsor's Biostatistics Functions

Case Study | Worldwide Flex

Discover how a rapid mid-study data transition rescued an endangered clinical trial, cleaned up compromised data, and secured a critical interim database lock within twelve months.

Your 6-Step Path To AI-Ready Data

E-Book | Sikich

Struggling with siloed or inconsistent trial data? This guide outlines a clear path to cleaner, governed, AI-ready datasets.

Top 10 HEOR Trends Report

Article | ISPOR—The Professional Society for Health Economics and Outcomes Research

Emerging trends in HEOR reveal how AI, real‑world evidence, value‑based care, digital health, and evolving affordability pressures are reshaping global healthcare.

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