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March 2, 2023

Quality Tolerance Limits: A Review of Industry Trends

An expectation for the use of quality tolerance limits (QTLs) was formally established in the International Conference for Harmonization (ICH) E6 (R2) GCP guideline published in 2016.

Guide

A Comprehensive Guide to Adaptive Site Monitoring

Blog

Leveraging RBQM In Ways You Never Envisioned

Risk-Based Quality Management (RBQM) is fast becoming a staple in clinical research, and the community is...

Blog

Risk-Based Study Execution (RBx) – It’s Time To Close The Loop!

Transforming RBQM into Proactive Quality Actions When the journey began, the focus was clear: monitoring. The...

Blog

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...