During the last two decades, process improvement was a dominant movement in the manufacturing industry. However, pharmaceutical and biopharmaceutical companies did not broadly recognize how breakthrough process improvement methods could be integrated with clinical research practices. Although Six Sigma is interdisciplinary, its internal structure and the nature of its interactions with other disciplines in clinical development organizations were not studied in depth. It is clear that using the strategy and methodology of Six Sigma can lead to breakthrough improvement of cycle time and error reduction in conducting clinical trials.

Workflow improvement is characterized as the implementation of deliberate and fundamental changes in business processes to achieve breakthrough improvements in operational performance. The broad organizational focus and deliberate nature of process improvement suggest a planned change in which a successful project requires preparation and deliberate action, commitment from management, technical competence, and mitigation of resistance to the change.

The early 1990s ushered in an organizational race to implement business process reengineering and reduce wasteful workflow activities. Academic researchers and practitioners have proposed many methodologies such as total quality management (TQM) and Six Sigma for applying statistical process control. Improvement of workflow or business process redesign is a step-by-step method of increasing an organization’s efficiency by analyzing how information flows and how decisions are made.

Improve the Procedures Projects Follow

J. McCormick, in the article “Success of Bpr Depends on Choosing the Right Analysis Method” in Government Computer News (No. 23, 1997), states that the success of workflow improvement mostly depends on the management decision-making, and that improvement efforts should focus on improvement of the procedures that projects follow rather than on the projects themselves. He identified two paradigms that are useful in viewing the improvement procedure – process-based (how people work) and data-based (how data moves). He recommends workflow definition followed by examination of functional decomposition, and the use of process and data maps for determining gaps within an existing organizational structure. The Six Sigma methodology provides a means for accomplishing this objective, matching client expectations (voice of the client) to process output (voice of the process) to define opportunities for improvement.

The Six Sigma improvement initiative has had a major impact on the culture, operation and profitability of several of the largest companies in the United States, including General Electric, AlliedSignal, Lockheed-Martin and Motorola. In Mikel J. Harry’s article “Six Sigma: A Breakthrough Strategy for Profitability” in Quality Progress (May, 1998), he describes the Six Sigma initiative as “a program aimed at the near-elimination of defects from every product, process and transaction.” When used as a metric, Six Sigma technically means having no more than 3.4 defects per million opportunities. The methodology uses a highly disciplined and statistically based approach for removing defects from products, processes and services.

Few pharmaceutical firms are listed among more than 300 member companies of the International Society for Six Sigma Professionals (ISSSP). While this suggests that Six Sigma is not extensively deployed by many pharmaceutical companies, use of the methodology can help pharmaceutical companies improve clinical trial performance.

Suggestions for Strategies for Pharmaceutical Industry

The following 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.

Using technology alone does not offer a viable solution if business processes are not streamlined and optimized to take advantage of the speed and robustness that technology can offer. In the highly regulated pharmaceutical industry, documenting processes is a critical element in the demonstration of quality and is considered concrete evidence for regulatory approval in marketing new drugs. However, if defects and inefficiency exist from the continued use of traditional clinical research methods, documented evidence will continue to carry defects and inefficiencies.