Regulatory Insights

  1. The Growing Complexity Of Conducting Oncology Trials 11/17/2025

    As diversity plans and multi-regional considerations become core to trial design, early-phase oncology programs must navigate a landscape that offers unprecedented opportunity.

  2. Dose Optimization: A Strategic Lever In Oncology Drug Development 11/17/2025

    Targeted therapies, immunotherapies, antibody–drug conjugates, and other biologics demand a patient-centered strategy that recognizes that higher doses do not always translate to better outcomes.

  3. New ICH GCP Changes Center The Patient 11/7/2025

    Learn how the updated ICH GCP E6(R3) guidelines are transforming clinical trials with a focus on patient centricity, digital innovation, and risk-based quality management.

  4. Clinical Trial Disclosure Fundamentals 11/7/2025

    Failing to comply with disclosure rules can leave sponsors open to fines and penalties. Here, we present the latest disclosure requirements, enforcement mechanisms, and tips on how best to stay compliant.

  5. The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection 11/7/2025

    A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.

  6. Expectations For Plain Language Summaries Continue To Evolve 11/7/2025

    Plain language summaries (PLS) are growing in importance as a requirement in global transparency. Focusing on protocol and results summaries, we cover expectations and best practices for global PLS implementation.

  7. How Emerging Technologies Are Challenging Traditional IRB Oversight 11/6/2025

    Uncover how sponsors, CROs, and study monitors can navigate FDA expectations and Institutional Review Board (IRB) requirements when integrating AI and Software-as-a-Medical-Device into clinical trials.

  8. How AI-Enhanced CAPA Systems Actually Work 11/6/2025

    Learn how AI can accelerate root cause analysis, predict quality risks, and streamline CAPA without compromising compliance or overwhelming your team with practical strategies.

  9. Maintaining Compliance In Gene Therapy Trials For Neurological Conditions 10/29/2025

    To identify efficacious treatments for neurological conditions, drug sponsors must design ethical clinical trials that protect participants and caregivers while ensuring compliance with regulators.

  10. Ensure IRB And IBC Success For Your Gene Therapy With Strategic Planning 10/23/2025

    To successfully bring innovative gene therapies to patients with neurological disorders, drug sponsors must design safe and compliant clinical trials with rigorous approaches to ethics and consent.