A Case Study in Quality Risk Management

A Global Pharmaceutical Company Automates QRM of Clinical Trials


After introducing a new Integrated Quality Management Plan (IQMP), a global pharmaceutical company realized their Quality Risk Management (QRM) process for conducting clinical trials had room for improvement. The IQMP monitored quality on high level issues to ensure that risks to quality were clearly identified and the proper mitigation plans could be set. Including the new IQMP in their QRM was an initial improvement that would provide a list of critical-to-quality attributes for each clinical trial to adhere to, but there were lingering issues with compliance and metric tracking that needed to be addressed.


The company manually defined the IQMP and tracked metrics using shared documents, but they quickly realized a central repository was necessary to move this isolated, individual process into an integrated, enterprise-wide solution. To do so, the process would need to be digitized.


VISTECH reviewed the requirements outlined by the company and researched industry best practices.  Core to the IQMP was the ability to define and quantify decision making, and VISTECH added key domain expertise as it had experience with a well-known, standard decision analysis process.  VISTECH worked with the company to design a process for identifying the appropriate IQMP for any unique trial by leading the user through questionnaires that collect clinical trial quality metrics to produce an overall weighted score, providing a single, easily visualized quality and risk indicator for each pivotal or non-pivotal trial. VISTECH created a web application that defined critical to quality risks, ranking them by failure modes and effects analysis. VISTECH automated the process of identifying those risks as well as prioritizing and isolating prevention and mitigation actions. The resulting solution allowed the appropriate specification limits for quality metrics to be identified, which ultimately eliminated manual practices, increasing organizational performance and reducing time-to-market.


​With its ability to produce an Integrated Quality Management Plan for each clinical trial, the new solution brought improved patient safety and regulatory compliance.  Identifying the specific quality metrics, risks, and mitigation plans for the protocol being assessed is now a standard business practice, not just an idea on the whiteboard.  The company assessed the data tracked in the system to refine their processes, which resulted in continuous improvement in the quality of their clinical trials.  Working with VISTECH allowed the company to realize the importance of total quality management

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