RBQM Resources

1. 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.

2. 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.

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. 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.

5. 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.

6. 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.

7. 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.

8. 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.

9. Digital Health Solution For CRS Detection And Prediction 2/27/2025

   Explore how digital health technologies offer a data-driven solution to cytokine release syndrome (CRS) monitoring, reducing inpatient care requirements while ensuring patient safety.

10. 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.