Six Sigma Tools Offer Proven Clinical Trial Benefits

“Outside of the corporate world, the Six Sigma name can be intimidating, and it doesn’t have to be,” says Betsy Fallen, a consultant with BAFallen Consulting LLC, of the widely used set of techniques and tools for process improvement. “Six Sigma provides tools that you can use every day. You may be using these tools already on a regular basis and not realize it.” Leveraged effectively, it can improve efficiency and oversight capabilities, as well.

According to Fallen, organization leaders and project managers, as well as chief information officers and their teams, can also deploy Six Sigma to eliminate redundancies, clarify accountability, and refine activity sequence. “With Six Sigma, it is easier to see what process looks like from end to end, including deliverables and the concepts along the way,” she notes.

“The key thing that I see and hear about is that Six Sigma simplifies,” Fallen continues. “Many organizations don’t need a system requiring an extensive license when some of the tasks can be accomplished easily with readily available tools that most researchers have on their desktops.”


Applying Six-Sigma Tools and Concepts to Your Clinical Research Activities

The typical tasks that clinical researchers do every day can be improved so that less time is spent and increased quality can be injected. Join expert speaker Betsy Fallen at ACRP 2019 this April for an overview of Lean Six Sigma and how you can leverage process improvement methods in your clinical trials.

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In Fallen’s view, Six Sigma is acutely important now for its ability to optimize processes by 10%, and in some cases, up to 50%. “You can identify reduction in work and cycle time. Effective systems don’t need to be sophisticated end to end to work,” Fallen says. Six Sigma can help define what is needed and what is not.

“Often, very inexpensive methods are possible,” Fallen adds. “[It’s a great resource if] you’re looking to improve and make defects less impactful or less frequent. The system definitely applies to the business capabilities in clinical research. A streamlined version could really benefit clinical research professionals.”

Author: Michael Rizzo