Former FDA Auditor Says Monitoring Has Gotten Sloppy and Sponsors Are Not Happy With CRO’s

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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 being viewed by the FDA and why many in the industry believe that monitoring has been really sloppy as of late. There were many interesting things that I learned during this mini-interview but the most striking was probably the fact that Sponsors routinely report CRO’s to the FDA anonymously for lackluster clinical trial management! This would add some further support to my theory that Sponsors are using this time of low study activities to square off CRO’s against each other and see who can perform better. I could not believe this, but apparently it occurs quite a bit. There are many other insightful findings here and I hope you find a few helpful.
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20 Percent Of Research Clinics Trigger 80 Percent of the Risk Based Monitor Activities

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Ah, the 80/20 rule in action yet again! For those who do not know, the 80/20 rule explains how 20 percent of an input creates 80 percent of the output or results. In today’s example, we have an illustration of how 20 percent of clinical research sites, for a number of reasons, end up triggering 80 percent of the risk based monitoring activities. The reasons are generally negative such as amount of queries generated, lack of adverse events reported, not following Good Clinical Practice, etc. A few are for good reasons, such as being high enrollers. Just wanted to share this with you and hope that it helps your Site not end up on the wrong side of the risk-based monitoring equation!

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Clinical Trial Supply and Demand and the Sponsor-CRO Relationship

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In today’s video I share some anecdotal evidence of a particular trend I am seeing as of late in clinical research: Sponsors choosing two CRO’s to conduct virtually the same protocol and then, through risk-based monitoring, assessing which protocol they want to stick with (if any) and which study they will cancel. I have seen this personally occur three times this year while hearing the same from others in the industry at both the research site and CRO level. I do not believe this is a long term trend, rather I see this as a direct result of the relatively low supply of clinical trials this year and the high demand amongst CRO’s to want to win these studies. When study activity picks up next year, I think we will see less of this but at least for now, this is what we have to deal with.

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Help! My PI Doesn’t Want To Go To The Investigator Meeting, My Research Clinic Is Not Getting Paid and More!

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In this week’s video/podcast I cover a multitude of topics and get back to a bunch of viewer emails. The usual topics such as negotiating budgets and getting more studies are covered, but my favorite this week was a Site that almost turned down a study because their Principal Investigator din’t want to go to the Investigator Meeting! Under no circumstance should you ever do this. It is actually quite common for PI’s to refuse to go to IM’s, and while it may not look great for the Site, you will not lose the study. I hope you enjoy this video, and keep the questions rolling!
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How A Research Clinic Can Pay Recruiters And Business Development Staff

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In this video I answer a viewer question on what are some of the best ways to pay patient recruiters or even business development staff. Hope it is helpful!

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Should A Research Company Have A LinkedIn Corporate Profile?

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The answer, as you would imagine from me is a resounding YES, but let me tell you a few reasons why it is important to have one.

-A good way to interact with employees and perhaps recruit future employees

-An excellent way to generate interest in your organization from Sponsor’s, CRO’s, and even potential study participants

but my favorite reason is…..

-Targeted ads!!! That’s right targeted ads are soon going to be available on LinkedIn where you can create an ad that will show up in the news stream of any specific job titles that you target. If you want more studies, just run a targeted ad aimed at Project Managers at various CRO’s and Sponsors! The challenge here will be to provide some content that will make it interesting enough for the individual to actually click on your ad. In other words, don’t make it look like an actual ad, but provide a valuable piece of content that also promotes your company’s services.

I am really excited about this and if you would like me and my team to work with you on these kind of targeted ads, send me an email or call me (you can find my contact info in the “My Bio” section of this blog).
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