White Paper

Enterprise Quality Management Of Clinical Trials

Source: Bioclinica

By Kristin Mauri, PMP Senior Director Global Consulting, eHealth Solutions, Bioclinica

Although it would be hard to find two people who describe TQM in the same way, important elements that are usually noted include organizational involvement at all levels, customer focus, and results that are measured, analyzed, and reviewed by management both quantitatively and qualitatively. Another important point of TQM is continuous improvement. Most supporters would agree that as new technologies or insights become available, it is the responsible of company leaders to be open-minded to evaluating them and if it appears that they can help to achieve higher quality results and continue to satisfy or exceed customer expectations, they should be incorporated as modifications to the original quality management system.

Although TQM is rarely mentioned today, its principles are dynamically incorporated into global initiatives such as ISO 9000, Lean Manufacturing, or Six Sigma, that carry on the solid foundation aimed at strategically focusing on purpose and quality before taking action.