Current Edition

The Bigger Picture of ICH E6 R2: Looking Beyond Compliance

The introduction of ICH E6 (R2) this past year has rendered the
implementation of risk-based monitoring principles a matter of GCP
compliance. While clinical research organisations across the industry
are now finally compelled to study the new guidance in order to roll
out a compliant risk-based monitoring (RBM) strategy, many are
still not recognising the incredible opportunity presented by this
paradigm shift. Steve Young at CluePoints suggests that instead of
viewing the updated ICH guidance as an exercise in compliance,
sponsors and CROs need to look beyond simple compliance and
towards the transformational improvements they can achieve across
their clinical development franchise.