Regulatory Insights

  1. 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.

  2. 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.

  3. 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.

  4. How Sponsors Can Drive Success With Central eSource At Investigator Sites 6/17/2025

    Centralized eSource systems enable complex clinical trials to align with key regulatory frameworks, including ICH E6(R3), ICH E8(R1), and 21 CFR 312, to meet the highest standards of GCP.

  5. Validating Generative AI: A Framework For Reliability And Compliance 6/16/2025

    With structured CSA-driven validation and expert guidance, organizations can harness generative AI’s advantages safely and effectively, ensuring accuracy, compliance, and operational excellence.

  6. FDA Shifts Reshape Drug Development 6/13/2025

    Listen to regulatory leaders share CRO insights on how FDA changes are reshaping global clinical trials, sponsor strategies, and investment trends in a new podcast series debut.

  7. We Need Regulatory Clarity—Not Complexity In Clinical Trial Technology 6/12/2025

    The current U.S. deregulatory momentum should not diminish compliance standards but instead serve as a call to streamline and modernize regulatory guidance.

  8. Mastering GMO & Companion CDx Trials: The EU Regulatory Playbook 6/12/2025

    This presentation offers strategic and operational guidance for navigating the regulatory challenges of conducting gene-modified organism (GMO) trials in Europe.

  9. A Roadmap To Expedited Review Pathways 6/12/2025

    Accelerated development and manufacturing timelines provide developers with paths to move new therapies to market quickly while still maintaining a balance of risk/benefit assessment. 

  10. The Central And Eastern Europe (CEE) Clinical Trials Report 6/10/2025

    This 2024 Industry Pages report provides an in-depth examination of the Central and Eastern European (CEE) clinical trial strategy, highlighting its pivotal role in global drug development.