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

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...

Blog

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...