Here is a hypothetical but surprisingly also regular occurrence: Dr Smith is conducting a clinical trial for Botech XYZ, Inc. which is a publicly traded company. Dr. Smith also owns stock in this company. Would this be allowed? When would he have to disclose this and after how much of an investment? Any potential for insider trading? Get all this and more answered in my latest video.
Today’s video/podcast answers more viewer/listener questions. The topics I speak about specifically are the latest technologies that may be able to help clinical researchers recruit more study participants. I also get into negotiating contracts and budgets with study Sponsors, and last but certainly not the least important topic: how to avoid bad business deals in clinical research!
I was able to interview Prasad Sristi, CEO of Mindprint Solutions. Mindprint helps CRO’s efficiently run their businesses by integrating various layers of software in order to allow the CRO’s to focus on their core competency: drug discovery, development and clinical trial management. Prasad shares some of the insider knowledge with regards to how CRO’s negotiate their budgets with Sites, what business activities generate the most profit for them and we even get into the topic of remote monitoring. This was one of the better interviews I have conducted in some time as the behind the scenes insight into how a cro operates was valuable. I hope you find some of the findings helpful from this interview!
Well this is a first for me! I got word from one of my research clinics that Medicare called them demanding the names and contact information for all of the study participants in a particular study protocol as they were making sure that the study Sponsor (Pharmaceutical company) will pay for the costs associated with medical bills and hospital stays that patients incurred and Medicare covered that were related to clinical trial adverse events and serious adverse events. This may be a game changer going forward for our industry as there will probably be a requirement to invoice the study Sponsor for all medical bills associated with adverse events and serious adverse events. Should your clinic even comply with Medicare and potentially violate HIPAA? I am not a lawyer but will get one on the show very soon to discuss the legal implications of this. Stay tuned!
In this podcast/video I answer some viewer emails and cover topics such as:
-what are the differences between CRO’s and SMO’s
-how do you run a successful clinical research company
-how to properly train your employees and create a winning company culture
-following your standard operating procedures
-some recruitment strategies that actually work
and lots lots more!
I was asked a superb question last week and decided to do a video on this topic. I’ve noticed that in the past I have always skirted around the issue but never actually gave examples of what constitutes a reasonable budget, at least in the opinion of the study Sponsor. In this video I answer this question. For a more in-depth overview of contract and budget negotiations please check out this video.