RBQM Resources

  1. 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.

  2. Ask Sites What Technology They Already Use 6/12/2026

    Rosie Filling says sponsors should stop guessing and ask sites what tech they use so teams can design with sites, not just for them.

  3. Why Site Burden Goes Beyond eSource 6/12/2026

    Beth Harper explains why the real problem is broader than eSource and why sponsors should integrate around the systems sites already use.

  4. Site Tech, Integration, And Reducing Burden 6/12/2026

    Beth Harper, Rosie Filling, and Joe Dustin discuss site tech, integration, and how sponsors can reduce burden while improving flow.

  5. Managing Risk And Regulation In Clinical Trial Technology 7/31/2025

    Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement.

  6. Mitigating Study Risk With Performance Analytics 5/19/2022

    Performance metrics for supporting risk-based management can be great, however, this author tells readers why collecting and analyzing data after a study has begun may not be the best approach.

  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. 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.

  10. Outlook For 2025: New Forces Driving Pragmatic Innovation 12/30/2024

    Clinical data trends are evolving rapidly to reduce trial complexity, improve patient experiences, and shorten development timelines.