Regulatory Insights

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. HTA In Japan: The Glass Remains Half Full (For Now) 6/12/2025

    While Japan's current HTA system is seen as pro-innovation, potential reforms in 2026 could expand its scope, creating uncertainty for manufacturers in one of the world's largest markets.

  6. Early Access Program In France: How Much Of An Opportunity Is It? 6/12/2025

    Navigating France’s Early Access Program is more complex than ever. Amid declining approval rates and mandatory data collection, here’s what pharmaceutical companies need to know about the changing landscape.

  7. Inclusion Of Health-Related Quality Of Life (HRQoL) And Other Patient-Reported Outcomes (PROs) In FDA Labels 6/12/2025

    With a growing emphasis on patient-centric drug development, new research examines how frequently patient-reported outcomes are actually making it onto United States Food and Drug Administration labels.

  8. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  9. 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.

  10. 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.