Central Laboratories Featured Articles

  1. How The FDA, MHRA, & EMA Differ On Externally Controlled Trials 10/23/2025

    As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

  2. Continuous Evidence Generation — Including RWE — Remains Critical To Vaccine Development 10/23/2025

    President of Takeda's Global Vaccine Business Unit Derek Wallace discusses the importance of continuous, real-world data collection in the context of vaccine development in low- and middle-income countries.

  3. What Is Disease Progression Modeling, And When Is The Right Time To Use It? 10/16/2025

    With the help of Clinical Trials Transformation Initiative's Lindsay Kehoe, discover how disease progression modeling can improve trial efficiency, inform precision medicine, assist in regulatory decision-making, and more.

  4. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

    Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.

  5. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

    Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

  6. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

    Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

  7. Seriously … Are We Making Any Progress? 9/25/2025

    Ken Getz’s DPHARM talk revealed how ballooning data collection in trial protocols drives costs, delays, and site burden. New ICH E6 R3 guidance pushes for simpler, more flexible designs, but real progress will require collaboration — and restraint.

  8. 3 Ways Biotechs Can Relieve The Burden Of Their First Clinical Trial 9/23/2025

    Discover how non-profit partnerships, adaptive trial design, and real-world evidence can all play a part in helping biotech's successfully launch their first-in-human trial.

  9. Combining RWD And Machine Learning To Determine Meaningful Patient Populations 9/22/2025

    Combining RWD with advanced ML models offers a powerful and transformative solution to optimize patient recruitment.

  10. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.