Red Flags in Research
I am Dr. Jeff Kingsley and this is another edition of Riding in Cars With Researchers! We are doing a series for you right now on how you can consistently choose sites that will perform for you. Today we are going to talk about infrastructure.
High degrees of Infrastructure are predictive of successful performance for you on your research protocols. Do we do a good job as an industry of predicting which sites will perform? Absolutely not. Which is why we have to look for red flags. A red flag is not a hard stop. A red flag is simply a pause. A red flag is a “hey, we should look into this more deeply”. You will, nonetheless, choose sites that underperform from time to time. That’s because research is tough. Major league baseball is tough. You can be a major league baseball player and you don’t get a hit every time you get up to the plate. You certainly don’t get a home run every time you get up to the plate. But over time, over multiple times at bat, you perform. You perform far better than a college ball player, or a high school player. You perform better than an amateur baseball player. Research is the same. So we are looking for red flags. Today we are talking about infrastructure.
Look for Specialists
What should you look for? You should look for specialists. If you are talking to a research site that has a dedicated contract and budget negotiator, that’s infrastructure. That is an investment that that site made for you. The site doesn’t have a dedicated contract and budget negotiator to make their life easier, it’s an investment for you. A dedicated contract and budget negotiator has a higher degree of sophistication, can turn around those documents to you within 24-48 hours, and can provide you with the data and the logic necessary to approve or disapprove a negotiation. That’s something you should look for that shows that the site is more sophisticated than the average site. A higher level of infrastructure.
Another example would be regulatory. If the coordinator is also doing the regulatory work, that’s lower specialization, lower infrastructure. But a site with a dedicated regulatory specialist can perform for you more readily, will have fewer regulatory errors, they will have faster turnaround time, and they will ultimately serve you better. Other examples are a dedicated data entry person, or with technology, sites that have invested in Clinical Trial Management Software (CTMS), or eSource or eRegulatory Solutions? Those all serve you better in enrollment, quality, and timelines. That’s enhanced infrastructure and you should look for that in your sites.
Is It a Guarantee for Success?
Is it a guarantee? What about a site that has a low degree of infrastructure? I happen to be talking to a site right now along the eastern seaboard that will probably become a member of the IACT family very soon. They have a very low degree of infrastructure today and they perform beautifully. They are the exception, not the rule. Trust me! Look for high degrees of infrastructure, and more often than not, you will receive a higher degree of service. And it doesn’t come cheaply. Infrastructure is expensive. But the ultimate win is yours when you are getting consistently higher predictable enrollment, quality data, and faster timelines, with higher degrees of customer service. Look for infrastructure!
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