What is a Logistics Coordinator in clinical research?
Logistics coordinators are value-added facilitators of cell and gene therapy trial operations, sites, materials, and manufacturing.
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:
- The sites that collect the biological material at predefined timepoints
- The contract manufacturing company (CMO) that produces the investigational product derived from patients’ cells
- The central labs that analyze various biological materials (e.g., blood, urine, saliva, bone marrow, cerebrospinal fluid)
- The CRO team involved in the study, including the Clinical Research Associates (CRAs), Clinical Trial Manager (CTM), and Data Manager
- The sponsor, who in some cases is accountable for the management of slot allocation
A Single Point of Contact
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.
- Clinical Sites: The Logistics Coordinator fields questions pertaining to cell and biological sample collection, storage, and shipment, and works with the CRAs to address these issues. Responsibilities also include provision of slot dates, guidance on timing for patient identification and recruitment, and manufacturing process updates (especially if multiple releases are required), and collection and distribution of documents to facilitate administration of the investigational product to the patient. Given that most cell and gene studies require collection of multiple biological samples, the Logistics Coordinator also assists the sites with kit resupply as well as guidance on proper use of the kits.
- Manufacturing: The Logistics Coordinator updates the CMO on patient identification and recruitment, timing of apheresis, shipment of samples, and other site-level activities, and in turn conveys manufacturing information back to the sites. Depending on the sponsor’s needs, the person in this position also handles certificates of analysis and documents when the investigational product is ready for administration.
- Central Labs: The Logistics Coordinator informs central labs of site activation, kit requests, patient recruitment, cell collection, sample shipment, and other site-level activities.
- Sponsors: The presence of a Logistics Coordinator means there is one professional charged with overseeing the complex process of ATMP manufacturing, someone who resolves issues as they arise and interacts with all stakeholders as needed. This individual provides the sponsor with process updates and, especially in the case of shared responsibility, assists the sponsor in informing the sites about slot allocation.
Looking Beyond Cell and Gene Therapy Clinical Trials
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.
