The Increasing importance of data and data analytics in the Clinical Trial Management space

Hear from Derek Truninger, General Manager at PCI Pharma Services, San Diego, as he shares valuable industry insights and how he sees data and data analytics playing a more significant role in the Clinical Trial Management (CTM) space.

With over 14 years of experience at PCI Pharma Services, I take pride in connecting with every department, team member, and client, offering direction, feedback, guidance, coaching, and mentorship whenever needed. PCI San Diego has experienced substantial growth in recent years, resulting in the site footprint doubling in size. This expansion has increased capacity and introduced new capabilities, including downstream sterile fill-finish processes. The facility now offers an integrated end-to-end solution for filling and packaging vials, syringes, and cartridges, with promising prospects for further expansion.

Having played a vital role in the recent Sterile Fill/Finish expansion project, a solid organizational culture is essential for success. I work diligently to ensure that the San Diego facility is recognized as a preferred employer in the local community. My primary goal is to form a world-class organization built on solid quality principles, focusing on pristine customer service and driving a culture of collaboration, accountability, and ownership while taking pride in our role within the pharmaceutical industry.

In the future, from a clinical supply perspective, I see the market growing into larger, rest-of-world studies, which requires not only a more extensive reach from a CDMO standpoint but also a deep understanding of the regulatory requirements across global jurisdictions to ensure compliance, for example, varying labeling needs and import/export permit requirements. Of course, data and data analytics are central to effectively and efficiently managing clinical trials. The scope and depth of data used in clinical trials are growing exponentially, and advanced analytics is turning this data into actionable insights that significantly impact trial outcomes. Data will continue to play a more prominent role in the CTM space. This may be full integration with IRT Systems, ERP Systems, or full-scale inventory management solutions that can better manage clinical supplies by supporting faster, more intelligent, and more efficient decision-making processes, from initial planning to regulatory submission. As trials become more complex, data-driven insights are beneficial and essential in navigating modern clinical research challenges.


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