RBQM Resources

1. 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.

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

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

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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. 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. 

10. 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.