Delivering radiopharmaceutical trials through integrated clinical expertise

This article is part of Parexel's "Advancing radiopharmaceutical development" playbook series. This series offers insights across feasibility and site selection, patient-guided trail design, regulatory strategy, and supply chain and logistics management to support sponsors in this evolving market.  

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The critical chain: Ensuring seamless delivery in RPT trials

At Parexel, we meet regularly with potential new clients to discuss our approach to running their RPT trials. One way to gauge their experience with the conduct of RPT trials is by the questions they ask. If their first question concerns logistics, we know they understand the main challenge ahead. 

Often, the success or failure of an RPT clinical trial depends on how vendors, CROs, and site staff operate during “the last mile” of delivering the drug to a patient. Did the vendor transport it from the airport to the site’s loading dock, drop it off, and drive away? Or did they deliver it directly into the hands of waiting study staff, who rushed it to the appropriate on-site holding facility? Successful “last miles” are only achievable if logistics planning begins months or years in advance. Here are the key components of how we manage supply chains and logistics at Parexel:

• Take an integrated approach to planning.

The consequences of mismanaging a supply chain in RPT trials far exceed those for typical clinical research setbacks. Delays can lead to costly investigational products degrading and becoming unusable, jeopardizing patient dosing schedules and even compromising the integrity of trial data. Limited production sources make it challenging to ensure a reliable supply of radioisotopes. A traditional clinical trial approach, in which sponsors, CROs, and vendors operate with limited integration, does not work for RPTs.

The intricacies of RPT handling, from specialized packaging and transportation to strict regulatory guidelines and site-specific licensing, demand integrated upfront planning. When products may only be viable for a few hours, minor problems can quickly escalate into logistical nightmares. The tendency to view logistics as transactional, managed through arm's-length vendor relationships, can be particularly detrimental. 

At Parexel, we engage all the relevant stakeholders—including sponsors, clinical operations, feasibility assessment teams, laboratory personnel, regulatory experts, and, most crucially, specialized logistics professionals—to create a cohesive strategy from the start of trial planning. Sacrificing early-stage collaboration and communication in the name of budget can ultimately lead to much greater expenses through delays, errors, and the need for trial rescue efforts. 

This collaborative approach fosters a shared, comprehensive understanding of an investigational product's unique characteristics, including its stability profile, specific handling requirements, and potential logistical choke points. Rather than a sequential, often disjointed handover of responsibilities, we integrate logistical considerations directly into the clinical protocol design and site selection processes.  

• Dedicate a project leader for supply chain logistics.

We assign a supply and logistics project manager to every trial—this role is distinct from and in addition to the trial’s overall project lead. In our experience, the benefits of this approach are significant. This individual assumes end-to-end accountability for the supply chain’s seamless operation and ultimate success. Their responsibilities extend beyond merely coordinating shipments; they meticulously oversee every stage, from initial manufacturing release to final delivery and management. This encompasses proactively managing all the involved parties, such as specialized couriers and depot facilities, anticipating potential disruptions like transportation delays or customs clearance issues, and orchestrating effective contingency plans to minimize any impact on the trial timeline and patient experience. 

Supply and logistics project leaders examine each site’s processes for handling radioactive patient samples. For example, will samples need to be drawn in the nuclear medicine department or the oncology unit? Where will they be stored? In addition to vetting site procedures and workflow, supply chain project leaders work to provide sites with appropriate resources (within the on-site pharmacy) for preparing and storing RPTs, if needed. They must also consider what to do if patients cancel their dosing visit. Sites should be ready to dose another patient on short notice if possible. 

• Simulate dry runs of product shipments.

We organize and execute comprehensive shipment dry runs, with radioactive product labeling, to ensure the materials move through airports and ground transportation systems as they will during the trial. This tool has proven valuable for intricate international trials involving multiple regulatory jurisdictions and transport modalities. These detailed simulations—we recently completed several to Brazil and South Korea—allow us to identify and resolve unforeseen logistical challenges before they negatively impact the actual trial. The supply and logistics project manager also trains site personnel on the RPT’s specific handling, storage, and administration protocols to ensure consistent and compliant execution at each participating center. 

• Show unfailing respect for patients, providers, and site staff.

We respect providers’ and patients’ time and commitment to a trial by taking extraordinary steps to guarantee the timely arrival of IP. By planning in detail and pressure-testing our execution strategies, we reduce the administrative and operational burdens on site study staff. Also, we give patients a more streamlined and predictable experience of trial participation, which minimizes their anxiety and maximizes adherence. 

A reliable supply chain is an ethical and effective means of advancing RPT research. With proper orchestration, the last mile of RPT delivery should be the easiest, most reliable step, reflecting the comprehensive, end-to-end strategic planning and collaborative execution that preceded it.

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