Expert Insights On Data Management & Analysis

  1. Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure 3/20/2026

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

  2. How Important Are Medical Monitors Under ICH E6(R3)? 3/20/2026

    Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions.

  3. FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know 3/12/2026

    Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.

  4. When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down 3/11/2026

    Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.

  5. How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026 3/10/2026

    Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.

  6. FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

    The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.

  7. 4 Factors Changing The Way CRAs Monitor Trials 1/28/2026

    The way CRAs monitor is about to change. Regeneron's Patrick Floody discusses these four factors that will influence it.

  8. Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit 1/12/2026

    Opus Genetics CEO George Magrath, MD, discusses how the company introduced virtual reality-enabled assessments and relied on digital endpoints to better measure participants’ vision changes.

  9. What Is Win Ratio, And How Can It Be Used In Rare Disease Research? 12/17/2025

    Amber Salzman, CEO of Epicrispr Biotechnologies, explains how applying the win ratio in facioscapulohumeral muscular dystrophy (FSHD) could transform the way researchers evaluate therapeutic impact, enhance statistical efficiency, and improve trial design.

  10. Adaptive Trial Design Is Changing Oncology And Hematology Clinical Trials 12/16/2025

    Pfizer Global Development Lead, Clinical Development Oncology & Hematology, Shreya Badhrinarayanan, MD, explains how adaptive trials, enriched by AI and better data integration, are transforming oncology and hematology clinical research.