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December 7, 2022

The Eradication of False Signals in Monitoring

Risk-based approaches to monitoring clinical trials were brought to the forefront with an FDA guidance published in 2013.

Guide

A Comprehensive Guide to Adaptive Site Monitoring

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Decoding ICH E6(R3): What It Means for Risk-Based Quality Management (RBQM)

Authors: Frederic Blais, Jelena Pasimisina, Melissa Thomas ICH E6(R3) provides greater clarity on proactively designing quality...

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10 Steps for Practical RBQM Implementation for Your Business

Many clinical trial Sponsors and Contract Research Organizations (CROs) realize the great benefits of Risk-Based Quality...

Blog

QTLs: Where Are We, And How Much Further Can We Go?

Quality Tolerance Limits (QTLs) represent a significant advancement in clinical trial research, aimed at proactively identifying...