Current Edition

Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management

In November 2016, the ICH E6 (R2) Addendum to Good
Clinical Practice was implemented, delivering a breath of
fresh air for clinical trial sponsors and CROs who have been
looking for guidance on best practices for achieving true, riskbased
quality management during clinical development. Brion
Regan, Product Manager, ERT, introduces this Addendum and
presents the reasons why sponsors and CROs should adopt a
centralised approach to risk-based trial monitoring, oversight
and quality management now — to not only stay ahead of
guidelines and regulations, but also to reap significant benefits
across many aspects of clinical development.