RBQM Resources

1. 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.

2. 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.

3. 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.

4. 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.

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. 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.

7. 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.

8. 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.

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. 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.