Regulatory Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Best Practices For Operationalizing Global, Early-Phase Oncology Trials 9/10/2025

    In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.

  9. What's Next For Global Drug Development: What Sponsors Need To Know 9/10/2025

    Learn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.

  10. Reducing Risk In Clinical Trials By Exploring Ex-US Markets 9/10/2025

    How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.