3 Facts about Risk Based Monitoring you need to understand
Risk Based Monitoring is a new approach of study monitoring. This has been first emphasized as a better method to reduce quality issues by FDA in August 2013 and then EMA in November 2013. This approach is now also a requirement from ICH-GCP since November 2016 when the ICH-GCP E6 (R2) has been published. This new approach
5 facts you need to know about a CRO
Many biotech companies underestimate the importance of selecting the right CRO: they do not realise that they put their (very often) single asset into the hand of an external party. As a fact, multiple biotech organisations didn't make it simply because they selected the wrong partner for their venture. Here are a few facts we want