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. 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.

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. 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.

5. How Risk-Aware Are You? Establishing A Foundation For A Holistic RBQM Strategy 10/3/2022

   This paper highlights why the industry is moving towards RBQM and how sponsors can build a scalable approach that protects trial participants, upholds study integrity, and increases operational efficiencies.

6. elluminate Risk-Based Quality Management 10/24/2022

   Proactively manage your trials with a centralized platform for data-driven risk assessment and oversight.

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. 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.

9. 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.

10. 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.