Simple and Effective Risk-Based Monitoring Revealed: The Roadshow

Using a day in the life of a study team to showcase pragmatic Risk-Based Monitoring Implementation
– Copenhagen, Denmark - November 29, 2016
– Paris, France - November 30, 2016

RBM Check-Up & Risk Management
Review


Pfizer and CluePoints Join Forces to
Show how to ‘Remove the
“Risk” in Risk-Based Monitoring’

This webinar was recorded on September 12, 2016. The recording is now live!

The Ultimate Risk-Based Monitoring
& Data Quality Oversight Solution

– Integrated RACT, KRIs and Data Quality Assessment
– Technology Agnostic Software as a Service (SaaS)
– Supporting FDA, EMA and ICH Guidance

Start Your Clinical Trial on the Right Track

CluePoints’ Risk Assessment Categorization Tool
– Customize Categories in Order of Impact, Probability, and Detectability
– Adheres to TransCelerate and MCC Methodologies

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CluePoints® offers cloud-based Risk-Based Monitoring software to improve data quality, increase operational efficiency and reduce regulatory submission risk. The solution is used by all types of Sponsors, CROs and Clinical Technology Organizations to drive Risk-Based Monitoring (RBM) and Data Quality Oversight. It works by harnessing a unique, patent-protected engine comprising a comprehensive suite of statistical algorithms to ensure that no stone is left unturned in surfacing potential issues in both clinical and operational data.

No other RBM or Data Analytics product offers this entirely independent, unsupervised and technology agnostic approach which the regulators and industry as a whole now refer to as Central Statistical Monitoring (CSM). CluePoints offers unique advantages:

  • A proven statistical engine that rigorously interrogates both operational and clinical data
  • An integrated platform that combines Key Risk Indicators (KRIs), Overall Data Quality Oversight, TransCelerate’s RACT (Risk Assessment Categorization Tool) and Issue Tracking Management
  • Seamless integrations with EDC, CTMS, IRT systems and other data repositories
  • An ethos of continual improvement ensuring that industry needs are being served now but with a clear roadmap of how this approach will be shaping clinical trial management in future