RBQM Resources

  1. RBQM For Decentralized Trials: Two Key Areas Of Focus To Reduce Your Risk 9/26/2022

    This article takes a more in-depth look at Sections 5.0.5: ‘Risk Communication’ and 5.0.6: ‘Risk Review.’ in ICH-GCP E6 R2 to show how the implementation of RBQM can reduce issues and achieve holistic trial oversight in today’s complex decentralized trials.

  2. How Analytics Are Shaping The Future Of Clinical Trial Risk Management 5/26/2023

    Explore how analytics are revolutionizing clinical trial risk management and shaping the future of risk mitigation.

  3. Are You Aiming For The Bullseye Or Just The Target? 6/15/2023

    Learn what this author has to say about focusing on a clinical trial's outcome when developing Risk-Based Quality Management strategies.

  4. Repositioning Your CDM Team To Meet Digital Trial Demands 1/25/2023

    Consider these steps when repositioning your clinical data management team to unify cross-functional reviews and align processes and technology to meet the demands of digital trials.

  5. Using Risk-Based Monitoring To Focus On Timelines, Quality, And Budget 9/21/2022

    Tanya du Plessis, VP of Data Solutions and Strategies at Bioforum, and Rich Davies, VP of Solutions Expert at CluePoints, explain the principle applications of RBQM to Data Management.

  6. Using Holistic Risk-Based Oversight, We Can Focus On A Trial's Most Critical Factors 7/15/2024

    The industry anticipates a transformative shift towards embedding RBQM as a foundational practice in modern clinical research as a means to enhance trial efficiency and safety.

  7. ICH GCP E6(R3) Implementation: Practical Approaches And Real-World Considerations 11/21/2025

    Access the full brief to learn how a phased, 12–18-month approach can help you meet ICH GCP E6(R3) requirements with confidence and avoid the costly pitfalls many organizations overlook.

  8. The Future Of Clinical Trial Oversight 4/13/2023

    The future of clinical trial oversight will be shaped by the increasing use of decentralized trials, which require new approaches to data management. Discover how to leverage digital technology to enable a flexible approach to monitoring in today’s era of DCTs.