Regulatory Insights

  1. 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.

  2. 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. 

  3. Explore The 2024 Edition of Industry Pages™ — A Strategic Guide To Running Smarter, Faster, And Leaner Studies 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.

  4. The Benefits Of U.S. Biotechs Conducting Clinical Trials In Australia 6/5/2025

    As U.S. biotech investment continues to rise, cross-border collaboration and trial design innovations are expected to further solidify Australia’s role in the early-stage biotech development pipeline.

  5. Ensuring Compliance When Using Wearables In Clinical Trials 6/4/2025

    As wearable technology takes on a central role in clinical research, explore how its benefits can be maximized while navigating the increasing complexity of regulatory compliance.

  6. Decentralized Trials And Community-Based Research Execution And Compliance 5/28/2025

    The FDA's regulatory endorsement of DCTs enhances their credibility, offering a pathway to more inclusive and accessible clinical research that benefits both patients and sponsors.

  7. RWD's Significance In The Largest FDA-Funded IOL Study Of Pediatric Patients 5/28/2025

    With FDA grant support, the American Academy of Ophthalmology and Verana Health conducted the largest real-world study to date on intraocular lens (IOL) use in pediatric cataract patients.

  8. The Makings Of 'Regulatory-Grade' Real-World Data In Ophthalmology Using AI 5/25/2025

    Regulatory bodies like the FDA and EMA now prioritize real-world data in clinical research. Learn more about its value in enhancing drug development, regulatory decisions, and patient outcomes.

  9. How AI Is Shaping The Creation Of 'Regulatory-Grade' Real-World Data 5/20/2025

    Regulatory agencies such as the U.S. FDA and the EMA are increasingly recognizing the value of real-world data (RWD) in shaping clinical research and informing regulatory decisions.

  10. Mastering The Complexities Of Gene Therapy Document Writing 5/20/2025

    Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.