Written by Nicole M. Palmer and John R. Nocero
“Lightning is a discharge of static electricity that has accumulated as a result of collisions between ice particles in storm clouds. The return stroke of a lightning bolt travels at approximately 100,000 kilometers per second, which is one-third the speed of light.”
The pharmaceutical industry is booming! Even with a potential recession coming our way the industry is not slowing down. Sponsors often want their clinical trials up and running as fast as possible so that enrollment can begin. Depending on the site, they can be activated in as little as a few weeks or I’ve seen it take 180 days.
This leads us to, how can we get sites activated in a flash? Okay, not really a flash, but in considerably less time than the industry standard 1-3 months. Let’s take a look at what that process could look like.
First, what does your company’s SOP state on the process that needs to be taken for site activation?
Second, how has startup been defined in your study plan? Who is doing what and does everyone know about it?
Thirdly, ICH GCP E6 (R2) provides a minimum list of essential documents that must be present prior to the conduct of a trial. How can we retrieve, review and file final documents contemporaneously?
Look for potential bottlenecks, such as
Bottlenecks:
*Contract and budget negotiations can take a significant amount of time.
*Larger institutions take longer to activate.
*IRB/IEC requirements and meeting dates – many meet once weekly; you need to accommodate this.
*Competition studies at the site level.
*Adequate, qualified, and trained staff.
By tracking and having adequate documentation of your bottlenecks you can focus on the areas that need improvement to get your sites up and running at lightning speed.
Suggestions for improvement:
+Utilize technology to track cycle times
+Choose smaller institutions
+Get to know your sites
+Ask the right questions to the sites
Remember lightning discharges static electricity. Sites can’t stay static – they need quicker startup times. Enrollment depends on it.
As always, if you have a question or want to leave a comment, please feel free- I am happy to help and love to hear from you.
Resources:
Granular Level, LLC 
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