Todays video is all about the research clinics out there, and is a direct response to a question I received the other day. Basically, the research clinic hadn’t received a study payment for a particular study in several months, despite enrolling a good amount of study participants and having a contract with the Sponsor which stated monthly payments. In this video I suggest some strategies that I have tried myself, or have learned from my guest gurus on the program here. As always, I’m curious to learn of your experiences and how you were able to deal with these types of issues.
Today’s video features guest Guru and producer of our show Pat Stone. Pat is a former FDA auditor who is currently a consultant for numerous Pharma and CRO companies in the industry. He also does consulting work for research clinics through his company Tradestone LLC. This interview was one of our best ever, as we explored Pat’s book, and discussed many issues in the clinical trials and Pharma industry.
This video was inspired by Clinical Trials Guru show producer Patrick Stone. Pat is author of the book Bubble Gum Badge which highlights his experiences as an FDA auditor. This video is a sort of prequel to my upcoming interview with Pat on the topics covered in his book, but in this video we discussed a lot about the FDA in general as well as 483 forms. Hope you enjoy!
Today’s video attempts to answer the most fundamental question of all when it comes to clinical research: what is a clinical trial? I get a lot of questions every week regarding this topic, and while I haven’t heard too many perfect responses, I hope this video can at least help a few people out there understand clinical trials just a little better.
Received an excellent question the other day and decided to make a video about it. In clinical trials, the CRO or drug company sponsors assign “monitors” to audit the trial on a routine basis at various clinical sites. The trend lately has been to conduct remote monitoring visits, where the monitor doesn’t physically appear on site, but rather, conducts the visit via phone or internet. I share what I know about this trend and how it may affect your research clinic and your business.
In todays interview, I talked with regular guest guru Darshan Kulkarni of Kulkarni law firm . Darshan is a very knowledgeable attorney as well as a pharmacist who provides a unique perspective on clinical trial issues. In this interview we started off with an interesting phone call from one of our viewers in which we examined the ethical implications of some cancer trials, and the conversation branched off into more ethical issues as well as answering more viewer questions. Enjoy.