Risk Based Monitoring Resource Center

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PAREXEL Informatics

  • 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.



RBM articles section header


     Oracle Offers CluePoints Solution for RBM

     How eSource is Transforming RBM

     Triumph Research Announces RBM Platform

     The Current Status of Risk-Based Monitoring

     CluePoints, ACRES Partner to Identify Data Quality Risks

     Can RBM Influence the Data Quality and Patient Safety Inversely?

     RBM Data Reveals Site Screening Due Diligence Improves Retention

     A Structured Approach to Implementing a Risk-Based Monitoring Model      for Trial Conduct

     Introducing Risk-Based Monitoring at Cancer Research UK

     Alternative to Risk-Based Monitoring Could be Beneficial

     Five Essential Cornerstones of RBM Technology




Tools & resources

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.