RBQM Resources

1. 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.

2. 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.

3. 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.

4. 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.

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

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

7. 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.

8. The Future Of Clinical Trial Oversight 4/13/2023

   The future of clinical trial oversight will be shaped by the increasing use of decentralized trials, which require new approaches to data management. Discover how to leverage digital technology to enable a flexible approach to monitoring in today’s era of DCTs.

9. 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.

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.