Regulatory Insights

  1. Mitigating Risk With Ex-U.S. Clinical Trials 7/8/2025

    Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.

  2. Accelerating Trial Start-Up: CRO Best Practices For 2025 7/8/2025

    In 2025, accelerating clinical trial start-up is critical, and Clinical Research Organizations (CROs) are applying innovative approaches to drive efficiency in site activation, enrollment, and regulatory approvals.

  3. Live Biotherapeutic Products: Unique Quality, Manufacturing, And Nonclinical Considerations For Clinical Trial Entry 7/8/2025

    Live biotherapeutic products (LBPs) represent an emerging frontier in therapeutic development, harnessing living microorganisms to prevent, treat, or cure disease.

  4. CMC Strategies For Cell And Gene Therapy Development 7/2/2025

    The regulatory environment for cell and gene therapies (CGTs) is evolving rapidly, requiring sponsors to adopt a more strategic, integrated development approach.

  5. Project Optimus: Shifting Away From Maximum Tolerated Dose 7/2/2025

    Project Optimus represents a transformative shift in oncology, advocating for a more nuanced, evidence-based approach to dose selection, prioritizing patient safety alongside treatment effectiveness.

  6. Best Practices For Gene Therapy BLA/MAA Submissions 7/1/2025

    Medical writers completing gene therapy submissions require strategic placement, justification, and cross-referencing to fit unconventional data within a standard template.

  7. Expert Guidance For EU Gene Therapy And Companion Diagnostic Trial Regulations 6/27/2025

    This playbook provides a concise yet comprehensive roadmap for navigating Europe’s multifaceted regulatory environment when conducting gene therapy trials involving GMOs and CDx.

  8. Pioneering Cancer Research Meets Unparalleled Veeva Vault Integration 6/26/2025

    A biotech company revolutionizing cancer treatment faced delays due to a complex, error-prone document review process. Discover how integrating an innovative strategy transformed their workflow.

  9. Disclosure Management System: Build Or Buy? 6/19/2025

    Clinical trial disclosure regulations are tightening worldwide. In order to maintain compliance, sponsors must determine whether to build an internal disclosure management system or buy a solution.

  10. Key Updates To Implementing Regulation (EU) 520/2012 6/18/2025

    The evolving pharmaceutical landscape demands continuous regulatory adaptation to safeguard patient safety and ensure compliance.