Improving IRBs: A Case Study with Copernicus Group IRB


Applied Clinical Trials

Institutional review boards play a critical role in the clinical trial process, ensuring that human subjects are protected and treated ethically. In addition to our responsibilities to research subjects, we are obliged to provide our clients with streamlined, efficient review and support services. Over the years, we’ve taken a number of steps to improve our offerings.

One path we explored, after performing the intense internal audits required by ISO, was to begin looking at methods for reducing waste and limiting non-value-added activities, with eyes on improving response time and achieving 100 percent data accuracy in every submission. The exploration of numerous process improvement systems and methodologies led us to embark upon a Lean Six Sigma program in partnership with North Carolina State University’s Industrial Extension Service (IES).

The goal of the Copernicus Lean and Six Sigma (CLASS) initiative was the minimization of non-value added activities and the reduction of variation – eliminating rework, reducing costs and improving customer satisfaction, both internal and external. This is achieved through an employee team-based approach, led by a facilitator, which promotes employee empowerment and positive morale. Success is determined by measuring internal and external errors, client feedback and employee involvement.

The results of CLASS have been dramatic. Turnaround times have been slashed – including a 20 percent reduction in one of the most involved submission types generally handled by IRBs. Our shipping department has been streamlined and automated, vastly reducing technological redundancies and cutting the time needed to deliver documents to clients. And our (already low) error rate has been further reduced.

Having gone through the CLASS exercise, CGIRB leadership saw firsthand the benefits of the initiative nearly immediately.

Of course, CGIRB is not the only organization in the clinical trials industry to take advantage of Lean Six Sigma methodology. Check out our “Closing Thought” in this month’s issue of Applied Clinical Trials to learn more.

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