Risk Based Monitoring Resource Center

Featured Sponsors

  • Whitepaper − Running Smarter Trials with Data-Driven Monitoring

    This white paper examines the core components, prospective benefits, and broad principles for the adoption of a Data-Driven Monitoring solution and how it can substantially improve study quality, safety, and also reduce monitoring costs.

  • Factsheet: Clearer Concise Data-Driven Decisions

    Data-Driven Monitoring is a combination of risk-based monitoring, targeted monitoring and centralized monitoring. In this factsheet we look at the key features, benefits, what it is and what we can offer.

  • Infographic: Understanding Data-Driven Monitoring

    Data-Driven Monitoring establishes real-time data surveillance and adaptive monitoring as key governing principles for site and study monitoring. Here we take a look at the 4 key pillars of Data-Driven Monitoring.

  • Insight Brief: Mitigating Risk Using Risk-Based Monitoring

    RBM can produce faster, more efficient trials by identifying and focusing on the higher risk areas of a study, at both the scientific and operational levels, and utilizes resources accordingly to mitigate those risks. This insight brief examines how risk assessment and mitigation drive the strategic and operational plans for the life of a RBM study.

  • Infographic: A better approach to risk-based monitoring 

    Partner with QuintilesIMS, the RBM market leader, to reduce risks and costs, improve data quality, and enhance patient safety. Learn more about how you can execute your RBM trials with confidence by partnering with QuintilesIMS in our latest RBM infographic.

  • Insight Brief: RBM Improves Site Performance and Investigator Satisfaction

    Read this article to understand how your Investigator Sites can improve overall site performance; learn how to improve Site engagement, enabling higher patient engagement; and hear about new capabilities being used in risk-based monitoring study execution.






Tools & resources

Risk-Based Monitoring in Clinical Trials second edition, December 2014

Designing Risk Detection Metrics for Risk-Based Monitoring

Access an RBM position paper released by Triumph Research Intelligence.

Risk-based Monitoring: Industry Guidance on Adoption, Use and Outsourcing (paid report), ISR Reports

Risk-based Monitoring: Reduce Clinical Trial Costs While Protecting Safety and Quality (requires registration)


FDA Guidance: Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring

EMA Reflection Paper on Risk-Based Quality Management in Clinical Trials


videos / podcasts


Monitoring With the ICONIK Platform

Nuala Murphy, Executive Vice President, Global Clinical and Data Operations for ICON Clinical Research discusses how monitoring works with the ICONIK platform with Editorial Director Lisa Henderson...MORE

How RBM Impacts the Way Sanofi Handles Monitoring

Lori Convy, assistant director clinical research monitoring, Sanofi discusses risk-based monitoring...MORE



Applied Clinical Trials LinkedIn Group

Applied Clinical Trials magazine is the global, peer-reviewed journal whose coverage features the process of managing clinical trials at the intersection where pharmaceutical product developers meet the strictly regulated medical researchers who test their new drugs.


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