Monthly Archives

August 2018

The CluePoints & HighPoint Solutions RBM Roadshow is Coming to a City Near You!

By | Blog, News | No Comments

Since the initial publication of the ICH GCP guidelines, the way clinical trials operate has changed significantly. The ICH E6 (R2) addendum, which came into effect in June 2017,  encourages sponsors to develop a prioritized, risk-based approach to monitoring. However, despite the guidance, some sponsors are still unclear on how to achieve the “gold standard” for monitoring, study execution and oversight.