Expert Insights On Data Management & Analysis

1. RWD Helps Researchers Include More Patients In Lymphoma Research 4/2/2026

   Andrew Evens, DO, MBA, explores how outcomes research and collaboration across academic networks, registries, and industry partners are advancing more inclusive, data-informed approaches to lymphoma research.

2. Unlocking Biopharma Innovation With Real-World Evidence 3/30/2026

   Discover how how federated data networks, platform aggregators, and collaborative partnerships have evolved to meet the data demands of modern product development, regulatory strategy, and commercial success.

3. Bayesian Digital Twins Show Potential For Predicting Prognosis And Treatment Response 3/30/2026

   Learn how Bayesian digital twins are trained, validated, and trusted in clinical settings and explore the potential for integrating these models into interventional trials.

4. From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs 3/25/2026

   Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

5. A Clinical Machine Learning Operations (MLOps) Maturity Framework For Biopharma 3/24/2026

   Pharma has invested substantially in machine learning applications, but investment in the operational infrastructure — the MLOps layer — has lagged. The time to build that infrastructure is now — not after your next trial fails.

6. Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem 3/23/2026

   When a patient feels no effect or a worsening effect because a known treatment effect was or wasn't experience, that's the "nocebo" effect. Strategic Advisor Jama Pittman discusses how this effect could impact regulatory reviews.

7. 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.

8. 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.

9. 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.

10. 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.