RBQM Resources

  1. 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.

  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. 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.

  4. Practical ICH E6(R3) Oversight For Your Centralized Monitoring Strategy 3/17/2026

    Bridge the gap between fragmented data and ICH E6(R3) compliance. Learn to use unified data signals to catch consent errors and enrollment delays before they trigger audit findings.

  5. 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.

  6. 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.

  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. 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.

  9. 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.