RBQM Resources

1. 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.

2. Build Vs. Buy Vs. Partner In Life Sciences: Making The Right Call 3/21/2025

   Discover when life sciences organizations should develop technology in-house, buy off-the-shelf solutions, or form strategic partnerships, exploring the costs and risks that come with each approach.

3. 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.

4. 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.

5. 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.

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. 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.

8. 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.

9. 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.

10. 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.