Featured Article

November 27, 2018

Update on ICH E6 (R2) Guideline for GCP

The ICH E6 R2 Addendum is starting to have a significant, positive impact on clinical trial design – offering a real opportunity to inject efficiencies into clinical research and development.

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...