Featured Article

November 30, 2018

How SMEs Can Achieve Regulatory Compliance Through a Risk-Based Approach

Since the introduction of the ICH E6 (R2) addendum, the industry has seen a rise in the implementation of a variety of risk-based monitoring (RBM) methodologies and technologies.

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...