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.

 

ARTICLES FROM OUR EXECUTIVE EDITORIAL TEAM

RBM articles section header

Medidata Enhances RBM with Centralized Tool

Medidata and PPD Partner to Offer New Approach to Risk-Based Monitoring

Conquering RBM: A Story on Medtronic's Risk Based Management Methodology

Cluepoints Statistical Monitoring Used to Check Data Quality in Large Phase III Trial

Shifting Monitoring Paradigms: Challenges and Opportunities

JMP and SAS: Tech Behind RBM Analytics

MCC Metric of the Month: A 2nd Risk-Based Monitoring Metric

Objective Internal Monitoring Can Improve Trial Conduct

Cost and Quality Implications of RBM

RBM, Proactively Managing the Present

more articles / blogs

 

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)

GUIDES

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

TransCelerate BioPharma Position Paper: Risk-Based Monitoring Methodology

more content

 

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

More videos / podcasts

 

COMMUNITY

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.