RBQM Resources

  1. elluminate Risk-Based Quality Management 10/24/2022

    Proactively manage your trials with a centralized platform for data-driven risk assessment and oversight.

  2. What's Driving Data Innovation: Notes From The Front Lines Of Change

    Clinical data innovators prioritize risk-based quality management, standards, and closer collaboration with research sites. Many see AI as an important support rather than a top priority.

  3. 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.

  4. 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.

  5. How Risk-Aware Are You? Establishing A Foundation For A Holistic RBQM Strategy 10/3/2022

    This paper highlights why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies.

  6. Five Steps To Streamline Your Trial 7/27/2022

    Explore the solution for adequately verifying and analyzing data from wearables, remote devices, and other novel data collection modalities. 

  7. Digital Health Solution For CRS Detection And Prediction 2/27/2025

    Explore how digital health technologies offer a data-driven solution to cytokine release syndrome (CRS) monitoring, reducing inpatient care requirements while ensuring patient safety.

  8. 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.

  9. 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.

  10. Implementing ICH E6 (R3) In A Risk Averse Culture 11/14/2023

    Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.