RBQM Resources

  1. 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.

  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. 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. 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 as well as explore the costs, risks, and trade-offs that come with each approach.

  6. Implementing ICH E6 (R3) In A Risk Averse Culture 11/14/2023

    Get several pointers on how to facilitate a transition to an agile, multi-faceted, and continuous risk and issue management approach aligned with the Statistical Analysis Plan.

  7. 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.

  8. 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.

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

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

  10. 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.