Regulatory Insights

  1. Hidden Costs Of Data Cleaning: Build Quality At The Source 12/11/2025

    Hidden costs from downstream data cleaning slow trials and raise risk. Explore why building quality at the source accelerates timelines, reduces errors, and gives sponsors a competitive edge.

  2. Aligning Global Standards For ICH E6(R3) And Artificial Intelligence 12/11/2025

    Global standards and AI are transforming clinical research. Learn why mastering ICH E6(R3) and risk-based compliance is critical for data integrity and future success.

  3. MHRA International Recognition: Fast-Track UK Market Access 12/10/2025

    MHRA’s IRP accelerates UK approvals via trusted regulators, but faster authorization only translates to access when aligned with NICE evidence needs, pricing policy, and coordinated launch strategy.

  4. Accelerating Milestones And Reducing Regulatory Risk 12/10/2025

    Modern adaptive Phase 1 oncology trials speed timelines, refine dosing, and meet FDA standards, replacing outdated 3+3 methods to boost efficiency, safety, and regulatory success.

  5. Gene Therapy & CDx: Smarter Development 12/10/2025

    Gene therapy success depends on optimized vectors, robust trials, biomarker-driven strategies, and coordinated regulatory planning for companion diagnostics and FDA engagement.

  6. Europe At A Crossroads: Biotech Investment, Regulation, And Partnership In Real Life 12/10/2025

    Position your biotech for Europe’s next phase by aligning strong science, smart clinical strategy, and the right global partners to navigate funding, regulation, and growth.

  7. Should Sponsors Provide Source Document Templates? 12/9/2025

    Here, we debate sponsor-provided source document templates, weighing regulatory guidance, compliance risks, and operational impacts for smarter clinical trial documentation decisions.

  8. New ICH GCP Changes Center The Patient 12/8/2025

    Explore key changes to the guidelines and how they're transforming clinical trials with a focus on patient centricity, digital innovation, and risk-based quality management.

  9. FDA Guidance On Payment And Reimbursement To Research Subjects 12/5/2025

    Learn how ethical, fair, and timely payment and reimbursement strategies can support participants, enhance trial accessibility, and uphold regulatory and IRB standards.

  10. Does 'The Belmont Report' Provide Guidance For Patient Stipends? 12/5/2025

    Consider implementing fair and flexible stipend models that account for individual burdens to enhance diversity, equity, and participation in clinical trials.