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Former FDA Auditor Says Monitoring Has Gotten Sloppy and Sponsors Are Not...
I was fortunate enough to finally meet Pat Stone, the former FDA auditor who has appeared on this blog many times throughout the years. In this interview Pat and I discuss how risk based monitoring is...
View ArticleWhat Is A Trial Master File In Clinical Research?
In this video I answer a viewer’s question on what a trial master file is when it comes to a clinical research study. Essentially, this is where all the regulatory documents for a clinical trial are...
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Clinical Trial StartUp Costs, Regulatory, and the Importance of Hustle!!!
In today’s video, I dive into a grab bag of viewer questions. There are several interesting topics discussed such as Clinical Trial StartUp Costs, the necessity of having appropriate insurance in...
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Conducting Each Portion Of A Clinical Trial At A Different Location
A different research site design involving satellite locations is identified. Possible complications for such a site are explored. Not all research is done in a clinic. Inpatient trials also exist.
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How Much Money Can You Really Make In Clinical Research?
This video discussed ways to profit from a research clinic. A relationship between involvement and profit is explained. The perfect balance of involvement of time and money depends on each research...
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How Can A Study Coordinator Become A Clinical Research Site Owner?
One way to establish a research site is to first establish an LLC or fictitious name. One must also take a major step by finding a physician that will serve as a Principal Investigator (PI). One way...
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