RBQM Resources

  1. 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.

  2. 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.

  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. 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.

  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. 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.

  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. 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.