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.    


The Truth About Clinical Research Site Training Hint It's Free!

There are countless clinical research training vendors touting the importance of site training.  This training is indeed important, but what they do not tell you is that the only 3 trainings you will actually need from a practical perspective (excluding hundreds of medical assessments, etc) are Good Clinical Practice, NIH Protecting Human Research Subjects, and IATA (for those who will be shipping and processing lab samples).  The other good news here is that all of these are FREE to anyone with a search engine at their disposal (oh wait, that's all of us).

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.  

Questions On Electronic Informed Consents, the Future of Clinical Research, and More!

Creating so much content on YouTube these days that here we are in March and I am just now getting to posts from around the Holidays!  Ignore the giveaway contest at the beginning as I already had several winners, and get to the meat of this clinical research video jam packed with practical content!  In this video I discussed electronic informed consents, the future of wearable technologies in clinical trials, and also where I think the industry is headed in regards to big data, risk based monitoring, remote monitoring and more.  Check it out and let me hear your comments below!