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. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Using Risk-Based Monitoring To Focus On Timelines, Quality, And Budget 9/21/2022

    Tanya du Plessis, VP of Data Solutions and Strategies at Bioforum, and Rich Davies, VP of Solutions Expert at CluePoints, explain the principle applications of RBQM to Data Management.

  8. 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.

  9. 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.

  10. 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.