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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 documents need to be col…

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 to b…

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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

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