Featured Article

September 2, 2019

From RBM to RBx: The Keys to Successful Adoption and Implementation

The latest version of the Good Clinical Practice (GCP) quality standard insists that sponsors implement a risk-based approach to study execution, a methodology that is now widely referred to as “RBx.”

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...