What The 2016 GCP Revisions Mean For You In Clinical Research

2016 gave way for revisions to Good Clinical Practice guidelines.  I did a full writeup on that here. I also discussed my thoughts on the ICH GCP revisions in this video.    


What Does Donald Trump Mean For Clinical Trials, CRA's and The Rest Of Us in Clinical Research?

I interviewed Darshan Kulkarni, attorney and pharmacist and all around pharma expert, on what a Donald Trump presidency means for us in the clinical research industry.  I have also written several posts about this, most recently this one here.  


How To Improve Principal Investigator Oversight In Clinical Research

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.  

Do Not Put Your Contracts and Budgets in Your Clinical Research Regulatory Binders

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.  

What Is The Difference Between an IND and a NDA in Clinical Research?

Many people often confuse or use the acronyms IND and NDA interchangeably.  In this video I explain the differences in meaning between an IND and an NDA in clinical research.