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Trial Master File

Our top 10 Q&A on Trial Master File

1. What is a Trial Master File (TMF)? Each clinical trial comes with documentation of trial related activities, legal requirements and trial data. All trial related…

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 is more about using new technologies in order to have an ongoing review of data at site, country and global level …

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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 to share to help you succeed in your collaboration with a CRO. 1. Sites like working with CROs Indeed, the last CenterWatch s…

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