Many industries are borrowing from the fields of distribution and operations management to improve efficiency, and the CRO business is no exception. At Precision for Medicine, we have embraced this movement by introducing a new position called the Logistics Coordinator, who oversees and facilitates all logistics for sponsors’ cell and gene therapy trials.
The unique manufacturing process essential to the advanced therapy medicinal products (ATMPs) that cell or gene therapy trials evaluate is custom-built for this new role. The process starts with patient or donor cell collection to produce the biological samples required for product manufacture and experimental analyses. Flawless coordination is crucial because any mishandling of samples can yield costly errors that may jeopardize product development and even the trial itself. The Logistics Coordinator’s close oversight of the chain of custody ensures Good Manufacturing Practice (GMP) compliance at every step of the process, including constant monitoring of storage conditions and tracking of shipments.
The Logistics Coordinator position is central to all cell and gene trial interactions with:
Coordinating every aspect of a cell or gene trial requires exceptional communications and interpersonal skills. These skills, combined with a proactive approach to problem-solving, keen attention to detail, and the ability to oversee and track multiple processes, allow the Logistics Coordinator to serve as the central point of contact for study sites, the CMO, central labs, and the sponsor, ensuring streamlined communication with all parties.
The Logistics Coordinator's role needs not be limited to cell and gene therapy trials but can extend to any clinical trial that requires collection of biological material, especially those involving multiple samples or analyses performed by different labs. In that capacity, the position can mitigate the additional demands of biomarker research and can work alongside a virtual sample inventory management (vSIM) solution to facilitate centralized visibility into sample collection, processing, shipment, and storage status across siloed systems.
In short, the Logistics Coordinator will be an asset to any site, CMO, lab, or sponsor involved in sample-intensive clinical trials. With this additional support, all stakeholders can rightly focus on the clinical aspects of their respective areas of specialization, and on their mission of delivering therapeutic solutions to patients in need.
Tiziana Magnani is a Senior Project Manager at Precision in Milan, Italy. She has dedicated more than 20 years to project management and clinical research in different settings and brings more than 15 years of experience in the academic world and in the management of large multi-professional teams to Precision.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
