Clinical Trial Technology Editorial

  1. Human-In-The-Loop In AI Validation And Control: From Principle To Practice 4/28/2026

    Explores how human-in-the-loop oversight can move from principle to practice. with a risk-based framework for determining when HITL is required, how the human role should be defined, and what organizational factors influence its effectiveness.

  2. Reimagining Data Governance For The AI Era 4/24/2026

    Understand the persistent governance challenges that undermine AI initiatives and walk away with a robust blueprint for building a resilient, scalable, and ethically sound framework.

  3. Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3) 4/22/2026

    With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.

  4. Is It Time To Replace RECIST — Or Just Add AI? 4/16/2026

    Immunocore Chief Regulatory and Quality Officer Mark Moyer explains why new tools, including AI-based approaches, may better capture cancer treatment response than existing measures, such as ir-RECIST.

  5. AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research 4/16/2026

    Companies that successfully use AI are those that understand technology magnifies accountability. Anyone that fails to internalize that lesson could find themselves defending the very systems they relied on to bring those products to market.

  6. RBQM And Centralized Monitoring Need Action 4/10/2026

    After COVID forced sponsors to move faster than ever, many are now confronting a harder challenge: ownership. Marci Thear explains why RBQM and centralized monitoring only work when sponsors move beyond reviewing outputs and start acting on the signals.

  7. RWE Is Ready — Decision Making For Pharmaceuticals Isn't 4/1/2026

    Gorana Capkun of Merck, KGaA, Darmstadt, Germany discusses the growing role of real-world evidence in clinical trials, highlighting a gap between regulatory momentum and pharma adoption— and the challenge of turning data into better decisions.

  8. Building A Future-Proof, GxP-Compliant IT Infrastructure 3/31/2026

    Learn how a structured IT evaluation framework can help companies model total compliance costs, request vendor qualification evidence, and embed governance requirements into infrastructure selection.

  9. 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.

  10. 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.