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. 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.

  3. 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.

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

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

  5. 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.

  6. 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.

  7. 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.

  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. 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.

  10. 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.