The Ultimate Solution for Risk-Based Study Execution (RBx) & Data Quality Oversight

– Integrated RACT, KRIs, Patient Profiles and Data Quality Assessment
– Technology Agnostic, Cloud-based Software with Machine Learning
– Ensures compliance with ICH E6 R2 and FDA, EMA & PMDA Guidance

 

Is Your Clinical Trial
Data Inspection Ready?

Find out with CluePoints' site inspection readiness
service, RADAR™

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From RBM to RBx – A Risk-Based Approach to Study Execution

CluePoints® is a pioneer in the use of cloud-based Central Statistical Monitoring (CSM) software to drive improved data quality and integrity as part of a Risk-Based Monitoring (RBM) process.

The solution, service and its value have evolved significantly since its inception in 2012 and the solution now ensures compliance with ICH E6 (R2) for Sponsors, CROs and Clinical Technology Partners. CluePoints 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. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment and solution implementation you now have everything you need.

The result is increased operational efficiency, reduced cost and reduced regulatory submission risk as part of an industry shift to Risk-Based Study Execution (RBx).

 No other RBM or Data Analytics product offers this entirely independent, unsupervised and technology agnostic approach coupled with thought leadership and consulting expertise in RBM and Good Clinical Practice.

CluePoints Offers Unique Advantages:

Statistical Interrogation

A proven statistical engine that rigorously interrogates both operational and clinical data to determine the quality, accuracy, and integrity of clinical trial data.

Everything you Need to Drive RBx

An integrated platform that combines Quality Risk Management, Key Risk Indicators (KRIs), Data Surveillance, TransCelerate’s RACT (Risk Assessment Categorization Tool), Intelligent Patient Profiles and Issue Tracking Management.

Seamless Integration

Seamless integration with EDC, CTMS, IRT systems and other data repositories.

Change Management

Change management support to ensure that resources are optimally employed, and processes match regulatory expectations.

Continuous Development

An ethos of continual improvement ensures that industry needs are not only being served now but with a clear roadmap of how this approach will be shaping clinical trial management and data analytics in future.

Whatever Your RBx Need, We've Got the Solution for You!