One of the biggest issues that the Food and Drug Administration (FDA) has been focused on lately has been the lack of Principal Investigator (PI) oversight in the clinical trials that they manage. In this video I suggest some ways that we in the industry can improve PI oversight.
This is some very simple but practical advice for my research sites out there: do not put your contract and budgets in the regulatory binder. Instead provide a note to file that explains where these documents will be kept.
For those of us who work in the clinical research industry, we are sometimes unaware of the fact that Sponsors spend even more money on advertising and selling their drugs than they do on research and development to produce them. It is very easy for us researchers to get lost in our own little (big) segment of the industry to pay much attention to the sales aspect. In this video, Darshan Kulkarni joins the Guru Nation to discuss advertising and sales regulations when it comes to drug manufacturers, and what us researchers may be interested in learning more about. I hope this interview is able to provide some value for you!
In this video, I give a bird's eye macro view on the entire clinical trial process from the perspective of a clinical research site. I have noticed that I often get into topics with such great detail that the bigger picture is often difficult to observe. This video attempts to do just that, zoom all the way out so we can all have a better understanding and context that can make studying the nuances of this industry that much easier.