RBQM Resources

1. 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.

2. 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.

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. 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.

5. Five Steps To Streamline Your Trial 7/27/2022

   Explore the solution for adequately verifying and analyzing data from wearables, remote devices, and other novel data collection modalities. 

6. 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.

7. 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.

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. 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.

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.