INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Hidden Costs Of Data Cleaning: Build Quality At The Source

  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.

• Aligning Global Standards For ICH E6(R3) And Artificial Intelligence

  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.

• Should Sponsors Provide Source Document Templates?

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

• New ICH GCP Changes Center The Patient

  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.

• 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.

• 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.

• Navigating The AI And Regulatory Frontier For Clinical Operations, Supply

  12/5/2025

  AI is transforming clinical trials. Learn how strategic adoption and cultural readiness can unlock efficiency, resilience, and compliance in an evolving global landscape.

• Regulatory Comparisons For Starting First-In-Human Clinical Trials

  12/4/2025

  Engage early with regulatory and clinical experts to navigate evolving global requirements and ensure your first-in-human strategy supports downstream development and multinational approvals.

• How Mobile Clinics Advance Diversity In Clinical Research

  12/4/2025

  Mobile clinics reduce participation barriers, enable more inclusive trials, deliver representative data, speed timelines, and advance equity in research.

REGULATORY MULTIMEDIA

• Should Sponsors Provide Source Document Templates?

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

• New ICH GCP Changes Center The Patient

  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.

• Trials Without Borders: Episode 5

  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.).

• Beyond The Checkpoint — Next-Gen Strategies In Immuno-Oncology

  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.

• Empowering Patients And Tackling Orphan Drug Development Challenges

  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.

• EU GMP Annex 11: Compliance Strategy And Digital Solutions

  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.

• New ICH GCP Changes Center The Patient

  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.

• Clinical Trial Disclosure Fundamentals

  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.

• Expectations For Plain Language Summaries Continue To Evolve

  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.

• Beyond Traditional TRSM: Transforming Clinical Operations At Scale

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