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

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

3. 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.

4. Paperless Online Remote Source Document Verification 2/2/2026

   Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.

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. 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.

7. 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.

8. 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. 

9. 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.

10. 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.