Regulatory Insights

  1. The Hidden Problem In Early Phase Oncology Trials 9/23/2025

    Integrating patient-reported outcome measures (PROMs) can enable improved capture tolerability and optimize dosing decisions.

  2. Expand Bandwidth With A Trusted Regulatory Writing Partner 9/18/2025

    Find out how a mid-size biotech lacking the bandwidth, expertise, and resources to independently handle its regulatory writing requirements overcame this challenge.

  3. ICH E6(R3): 10 FAQ On What Changed And What It Means For Your Trials 9/18/2025

    The ICH E6(R3) updated guidelines present 10 critical changes to make clinical trials more efficient, adaptable, and patient-centric, while upholding the standards of scientific and ethical integrity.

  4. How AI & Biomarkers Are Reshaping The Next Frontier In Drug Development 9/18/2025

    Learn more about the importance of biomarker-driven drug development and the integration of laboratory science, clinical expertise, and regulatory strategy to accelerate targeted therapy development.

  5. Pre-IND CMC Checklist For Regulatory Success 9/17/2025

    Learn how to prepare CMC documentation that meets regulatory expectations, and explore key elements for a successful Pre-IND submission to avoid common delays in the review process.

  6. Understanding Decentralized Clinical Trials: FDA vs. EMA Fundamentals 9/15/2025

    Designing a global decentralized clinical trial requires understanding the differing FDA and EMA approaches to trial models and informed consent.

  7. Managing Drug And Data Requirements In Decentralized Clinical Trials 9/15/2025

    Running a global decentralized clinical trial requires a deep understanding of the differences in FDA and EMA requirements for investigational products and patient data.

  8. 5 Essential Steps To Implementing Decentralized Clinical Trials Globally 9/15/2025

    Running a global decentralized clinical trial requires a strategy that balances the FDA's focus on technology accessibility with the EMA's emphasis on validation and comprehensive documentation.

  9. Best Biostatistics Practices To Drive Clinical Trial Success 9/10/2025

    Utilize this checklist of best practices for biostatistics in clinical trials, from early planning to regulatory submission.

  10. The New Era Of Project Optimus: Implications For Oncology Development Strategy 9/10/2025

    In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.