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

    Strong biostatistical practices are essential for trial success. Utilize this checklist of best practices for biostatistics in clinical trials, from early planning to regulatory submission.

  7. 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.

  8. 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.

  9. GLP-1 Ocular Safety Monitoring At Point-Of-Need 9/8/2025

    Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).

  10. Five Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO 9/2/2025

    In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional; it is essential to survival and success.