RBQM Resources

  1. Validation And Why Sponsors Say Yes 6/12/2026

    Joe Dustin explains why validation documentation and sponsor benefit are key to getting approval for site-system integration.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Paying Sites To Reduce Burden 6/12/2026

    Beth Harper and Rosie Filling discuss site burden, enrollment pressure, and why sponsors should help pay for technology and training.

  8. 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.

  9. 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.

  10. 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.