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Audit Trail Review: A Novel Solution for Detecting Risk in ePRO Data

Now introducing...A statistical test designed to uncover data quality risks in multicenter clinical trials, with a focus on ePRO data analysis. Discover how this innovative approach empowers sponsors and investigators to proactively safeguard data integrity and ensure the reliability of study results.



The Risk-Based Data Management (RBDM) Revolution

Discover how RBQM’s proactive approach and RBDM’s modern analytics ensure risk management for data quality and participant safety in clinical research, adding valuable insights to every study.



In Case You Missed It:
Analysis & Insight into Drug Development Issues from Tufts Center for the Study of Drug Development

Approximately half of clinical trials use RBQM components. Download our report with Tufts CSDD to discover leading drivers and barriers behind sponsor and CRO adoption.


Schedule Your Risk-Based Monitoring Assessment and prepare for ICH E6 R3

CluePoints can help optimize your RBQM approach. Leverage our expert guidance for your organization—sign up for a Benchmark Analysis today.

From RBM to Risk-Based Quality Management

Before, it was about Risk-Based Monitoring. Now, it’s about Risk-Based Quality Management (RBQM), an ICH and FDA-advocated approach to managing risk for the entire clinical trial lifecycle. CluePoints provides the enabling technology and expertise to drive this new paradigm.

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Quality Tolerance Limits

Study or Patient Safety Risk using Quality Tolerance Limits.

Key Risk Indicator Dashboard

Site Risk using study-specific Key Risk Indicators.

Data Quality Oversight

Discovery of unknown issues through statistical interrogation of all data.

Issue Tracking

Integrated Issue and Action Management to manage resolutions.

Hover over the toggles to discover the features.

Got a Question?

Whether you’re looking to get started or need support, we’re here to help!

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Risk-Based Quality

CluePoints offers an array of solutions designed to help Sponsors and CROs quickly and efficiently identify, manage and document risks for the entire study lifecycle and ultimately, to drive compliance with ICH E6 (R2).

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Explore our

Risk-Based Quality

Our Subject Matter Experts boast unrivaled experience in the data quality oversight arena and can help you translate your quality oversight goals into a detailed strategy with a pragmatic roadmap for delivery.

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We're Kind of a Big Deal.


Platform Users


Studies De-Risked


Issues Detected
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