CTA negotiations can be a hurdle for trial initiation
The amount of clinical trial agreements (CTAs) that a “contract manager” or a “project manager” (or any other name used within a company to identify a non-legally trained person in charg…
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 be more proactiv…
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