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 quality risks were clearly identified, and that the proper mitigation plans could be established. 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. However, there were lingering issues with compliance and metric tracking that needed to be addressed.
There is an increasing need for companies to keep their information easily accessible and stored in one central location. It is extremely inefficient when IQMP is defined manually, and metrics are being tracked through shared documents. The Global Pharmaceutical Company quickly realized that a central repository was necessary to move from an isolated, siloed processes into an integrated, enterprise-wide solution.
VISTECH reviewed the requirements outlined by the company and was able to address the challenges by employing industry best practices. Core to the IQMP was the ability to define and quantify decision making. Due to VISTECH’s team of experts, who had prior experience with a well-known standard decision analysis process, key domain expertise was added to this project. 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. This provides a single, easily visualized quality and risk indicator for each pivotal or non-pivotal trial.
VISTECH created a web application that defined critical quality risks that ranked them by Failure Mode and Effects Analysis (FMEA). VISTECH then automated the process of identifying those risks as well as the process of prioritizing, and isolating prevention and mitigation actions. The resulting solution allowed the appropriate specification limits for quality metrics to be identified. This ultimately eliminated manual practices, increased organizational performance, and reduced time-to-market.
With its ability to produce an Integrated Quality Management Plan (IQMP) 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 a 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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