RBQM Resources

  1. Paperless Online Remote Source Document Verification 2/2/2026

    Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.

  2. 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.

  3. 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.

  4. 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.

  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. 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.

  7. 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.

  8. 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.

  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. Advanced Analytics To Power Action Across The Trial Continuum 10/18/2023

    Examine how Medidata's Clinical Operations solutions are working to improve the efficiency of study timelines through their platform, guided by interconnected workflows and data-driven insights.