Clinical trials are essential for the development and approval of new drugs. Lean and Six Sigma methods are useful in the clinical trial environment. We’ll look at their application and finish with a video on the four phases of clinical trials.


Lean and Six Sigma Potential Application in Clinical Trial Sites


An article titled “Pharmaceutical industry has fat to trim — How will that impact CT sites?” discusses how Lean/Six Sigma can help.

The Lean Six Sigma model “…is ideal for pharmaceutical companies and the research process, especially as the industry's profitability has reached its apex and as sponsors increase their focus on outsourcing for clinical research”

David T. Asher, MBA, MBB, a pharmaceutical consultant lists the questions that sponsors, and clinical trial sites should ask.

Douglas E. May, MS, a solution partner in life sciences practices gives examples of potential process improvements and waste elimination in clinical trials.

You can read the article here.


Lean Thinking Applied to New Medication Launch


In a short article titled “Launching new medication quicker with Lean Thinking” authors Augusto da Fonseca, Ludmila Xavier and Robson Gouveia discuss how Lean and Agile thinking can speed up the analysis and approval process in clinical trials.

The authors give the results of the application of Lean Thinking to one of Roche’s clinical trials.

You can read the article here.


Using Lean Thinking to Improve Productivity in Drug Discovery


In an article titled “Lean Thinking for Drug Discovery – Better Productivity for Pharma” author Edward W. Petrillos discusses how Lean Thinking can be applied to drug discovery.

From the author: “The goal of this article will be to show that improving the process by which leads are optimized during drug discovery can be as important as the underlying science, and that the means for accomplishing this improvement can be found in the methodology known as lean thinking.”

 You can access the article here.


Aiding Drug Discovery with Lean Six Sigma Principles


In a short article titled “Lean Six Sigma Principles in drug discovery research” authors Suguna Nandgaonkar and Ankasha Tejam discuss the need for Lean Six Sigma and the benefits of its application in drug discovery.

From the authors: “The application of Lean Principles and Six Sigma methodology can facilitate streamlining process metrics issues related to various phases of discovery experiments, reducing errors and the number of repetitive experiments thereby providing high quality data in short turnaround time and investment costs.”

 You can read the article here.


The Four Phases of Clinical Trials


Learn about the four phases of clinical trials in a video from kidneyfund.

You can watch the video here.




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