Regulatory Webinars

  1. 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.

  2. 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.

  3. Trials Without Borders: Episode 5 12/4/2025

    In Episode 5 of Trials Without Borders, we explore Canada's clinical trial ecosystem with expert panelists Erin Cherban (Chief Clinical Research Officer, Centre Advancing Health Outcomes/CIHR Pan-Canadian Network), Melissa Bomben (CEO, True North Innovation Agency and fractional COO of Biorasi), and Sergey Nikitin (Founder and President, Prime Site Research Solutions Inc.).

  4. Beyond The Checkpoint — Next-Gen Strategies In Immuno-Oncology 11/24/2025

    Gain a clearer view of the scientific, operational, and regulatory forces propelling the next wave of oncology innovation — and what they mean for sponsors advancing cutting-edge cancer therapies.

  5. Empowering Patients And Tackling Orphan Drug Development Challenges 11/18/2025

    Successful rare disease trial design requires patient-centric approaches. Experts share how to embed the patient voice, optimize site readiness, and balance feasibility with essential regulatory rigor.

  6. EU GMP Annex 11: Compliance Strategy And Digital Solutions 11/18/2025

    Explore how EU GMP Annex 11 revisions could reshape global pharmaceutical compliance, as well as strategies for navigating implementation challenges and building future-ready validation programs.

  7. 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.

  8. 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.

  9. 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.

  10. Beyond Traditional TRSM: Transforming Clinical Operations At Scale 10/3/2025

    Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.