Industry Insights

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 FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

    The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development.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.

  2. Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial 3/3/2026

    Discover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.

  3. The Uncomfortable Conversation: AI And Data Use In Clinical Trials 3/2/2026

    AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.

  4. When A Clinical Trial Surfaces In An AI Chat, What Happens Next? 3/2/2026

    AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.

  5. The Innovations Shaping 2026 CNS Clinical Trials 2/27/2026

    Explore how AI, digital tools, and site‑centered design can reduce burden, strengthen data quality, and support more reliable trial execution.

  6. The Cost Of Transactional Thinking In Clinical Research 2/26/2026

    Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.

  7. RTSM Reusability: What It Is, Why Most Systems Lack It, And Why It Matters 2/25/2026

    Explore why RTSM should be viewed as a system for managing change. Learn how platform-based reusability reduces UAT churn, preserves institutional memory, and stabilizes mid-study amendments.

  8. Choosing RTSM? Evaluate The Team Running It, Not Just The Software 2/25/2026

    High-performing RTSM requires more than just code. Discover why team continuity and clinical expertise are the most overlooked factors in reducing trial risk and ensuring regulatory compliance.

  9. Automation Testing In RTSM Software: What Is It And What's The Impact 2/25/2026

    Move beyond the limitations of manual oversight to see how automated frameworks ensure precision, speed, and reliability for the most sophisticated and adaptive clinical trial designs.

  10. How Modern RTSM Platforms Are Eliminating Delays 2/25/2026

    Stop letting rigid legacy RTSM systems stall your clinical trials. Learn why manual change requests cause months of delays and how a modern, platform-based approach restores your study’s agility.