In late 2016, the FDA revised the ICH GCP guidelines. You can read all about it on my news blog here. In this video I give my personal commentary on how I think this will affect Clinical Research associates and Contract Research Organizations.
Ever wondered how Contract Research Organizations select which Clinical Research Associates will be put on which clinical trial? In this video I try to demystify this CRA staffing topic and discuss how the Sponsor can also tend to influence things.
In my process of launching my own CRO startup, I have broken down what a CRO typically does into tiny manageable chunks that we can look into and learn from. New business models are created when inefficiencies are discovered in the previous ones. In fact, the inefficiencies of the drugmakers during the clinical trial process is precisely what paved the way for modern day CRO's. These days, the riches are in the niches as new inefficiencies emerge due to new technologies.