Among the many challenges for clinical trial project teams, logistics is one of the most critical and complex. From project initiation to the first shipment of supplies, getting the right logistics in place is essential.
Early-stage operations, especially in multi-country studies, are complex and fast-moving. If logistics are not meticulously planned from the very beginning, even the best-designed trial has the potential to incurr costly delays.
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Some of the significant challenges identified by experts at Oximio from the early phases of clinical trial planning include last-minute requests to often-overlooked financial and regulatory hurdles, as well as planning for the unexpected.
The value of early engagement and collaboration with partners to ensure a smooth journey cannot be overlooked.
Listen to the episode below:
“It’s all about engaging with sponsors and clients early on,” explained Dr Zayheda Khan, Chief Commercial Officer from Oximio explains during the podcast. “That means getting a clear understanding of requirements from the very beginning. We need to be on the same page. We need to know exactly what clients are looking for – what are their requirements and expectations – long before the first shipment goes out. Without that, you’re just asking for trouble down the line. The better the communication is at the start, the smoother the whole project will be.”
Alongside these initial issues, start-ups must also address the potentially high number of unknowns. These include knowing how to navigate the complex, highly regulated world of clinical logistics for the very first time, something Oximio’s experts address in the podcast.
They explain how many start-ups often underestimate key elements in the early phase such as regulatory planning and the financial implications of shipping products across borders. In terms of the logistics for the movement of vital medicines or biological samples, the regulations and processes can be complicated, which the podcast explores further.
Budgets, forecasts, and the impact of variables on early-phase clinical trials
When it comes to budget pressures, start-ups are always impacted by the sheer volume of potential variables.
Smart project and budget management are essential to help optimise costs and ensure sponsors don’t face any unexpected expenses. Oximio has extensive experience in providing solutions in this area. Facing these budgets and how they are linked to logistics can be a considerable challenge.
“Planned budgets often underestimate actual logistics costs,” said Iryna Turkevych, Director of Project Management at Oximio, in the recent podcast episode. “Project managers are expected to manage within scope, without sacrificing delivery. It’s not just about controlling costs but about anticipating them. The key is early, realistic planning paired with ongoing monitoring and stakeholder transparency. At Oximio, we start by building the budget alongside the logistics strategy — mapping out country-specific requirements, temperature controls, storage durations, customs fees, and potential risks.”
Throughout the project, it is vital to track actual costs versus projections and flag any deviations at the earliest possible stage. If a change occurs – such as an added country or urgent shipment – waiting for invoicing to update this is not an option.
As the Oximio team explain, the need to assess such impacts, inform the client, and propose potential alternatives is of paramount importance. Podcast listeners will learn how good budget management is about partnership and making sure sponsors feel in control – even when factors change.
Preventing delays at borders for clinical trial shipments
In clinical trials, managing regulatory hurdles and preventing customs delays is critical. This was further explained by Dariia Bondarenko, Senior Import/Export Specialist at Oximio, who identified the complex nature of clinical trial imports and export procedures.
“Clinical trial logistics aren’t just about moving boxes, they’re about orchestrating a series of interconnected events, each with its own challenges,” said Bondarenko during the podcast. “Clients need to understand that a shipment cannot simply be dispatched without everything in place: the documentation, the financial and contractual arrangements, and the necessary regulatory approvals.”
As the podcast also explains, those involved in these projects cannot just ship a package and hope for the best. In clinical trials, every shipment represents patients, timelines, and trust. It is ultimately the import-export specialists who ensure all of those stay protected.
From project managing the unknowns to early phase planning for cost considerations, there are myriad moving parts that combine to potentially further complicate clinical trials. With careful planning, solid contingencies in place, and experienced teams involved, the majority of factors can be mitigated.
Watch the full episode below and find out how Oximio helps sponsors and CROs manage the complexities and challenges in early-phase clinical trials:
