Six Sigma in Clinical Trials

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Six Sigma is a set of techniques, and tools for process improvement. It was developed by Motorola in 1986, coinciding with the Japanese asset price bubble which is reflected in its terminology. Six Sigma became famous when Jack Welch made it central to his successful business strategy at General Electric in 1995. Today, it is used in many industrial sectors.

Six Sigma doctrine asserts that:

  • Continuous efforts to achieve stable and predictable process results (i.e., reduce process variation) are of vital importance to business success.
  • Manufacturing and business processes have characteristics that can be measured, analyzed, controlled and improved.
  • Achieving sustained quality improvement requires commitment from the entire organization, particularly from top-level management.

Features that set Six Sigma apart from previous quality improvement initiatives include:

  • A clear focus on achieving measurable and quantifiable financial returns from any Six Sigma project.
  • An increased emphasis on strong and passionate management leadership and support.
  • A clear commitment to making decisions on the basis of verifiable data and statistical methods, rather than assumptions and guesswork.

Key strategies are suggested to launch a Six Sigma effort within this industry

  1. Begin to change the traditional ways of conducting clinical trials by campaigning for the implementation of needed integration initiatives through the use of Six Sigma with a commitment from top down leadership.
  2. Focus on the integration of technology and workflow improvement in meeting challenges and extend new ventures not possible using conventional isolated implementation of technology or homegrown process improvement methodologies.
  3. Provide tested research approaches for the quantitative evaluation of clinical development and process improvement strategies, the integration of which highly correlates with strong financial performance.
  4. 4.      Lean Six Sigma at the sponsor level
  • The use of new agreements, rather than reuse of previously negotiated ones, allowed for increased flexibility and nimbleness.
  • Clear communication plans were established, allowing CROs to efficiently escalate issues to sponsors. This effort allowed the sponsor to react and respond in a timely fashion.

Areas where the six sigma if initiated might help in clinical research:

  • Generating quality data which can be considered and authentic.
  • Better documentation and version control procedures.
  • Generating skills in the clinical research professionals which will help them to review documented data and check for compliance to regulatory and ethical guidelines.
  • Gain an understanding of to tackle imperfections and variations in drug discovery & development
  • Making industries can eliminate waste and minimize variation in process streams, thereby improving the quality, reliability and reproducibility of outcomes
  • To be able to optimize utilization of Key Performance Indicator
  • From a manufacturing standpoint to understand process capabilities and from a Quality Assurance/ Quality Control
  • Evaluation of access to new product benefits for the customer



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