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 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. 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.

4. 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. 

5. 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.

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. 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.

8. 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.

9. 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.

10. 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.