Demystifying Clinical Trial Logistics in Ukraine During the War
Logistics play a crucial role in the supply chain. Often complex and not without challenges, it encompasses a variety of sectors including food, equipment supply, people transfer, or medicine. Now, imagine the daunting task of having to manage logistics operations when your country is under attack or at war. Tragically, this is the reality in Ukraine. The ongoing conflict has had a profound and far-reaching impact on logistics across all industries in the country.
Olga Vizgalova, Managing Director of Oximio, Ukraine, recently welcomed the opportunity to present to industry figures at the European Integration Forum in Ukraine. Her subject “Demystifying clinical trial logistics in Ukraine during the war” gave an honest account of the challenges faced as a result of the conflict. However, it also highlighted the innovative and swift measures the company has taken to not only circumvent these obstacles but improve performance and procedures.
Things aren’t the same:
No aviation routes
Impacted country road infrastructure
Restriction on country coverage
Before the war, clinical trial supplies were transported by Avia to the international airport Boryspil in Kyiv. With Ukraine now a no-fly zone, this resulted in a quick and strategic reassessment of alternative flight routes to neighbouring countries and onward road transportation to the clinical trial destination. This was a complex situation as the war had affected infrastructures and routes had to be rapidly revised. Following initial restrictions when we couldn’t deliver, we have now managed to regain our coverage and deliver, as previously, to Kharkiv, Sumy, Chernihiv, Mykolaiv and Kherson.
Improving Performance
Despite the challenges, Oximio has pressed on to try and deliver the best service possible to meet their customers’ requirements. The team has not only maintained continuity but has seen opportunities to improve their offering.
Continuity and improvements included:
Quality of cold chain processes: operational and quality compliance delivering cold chain assurance.
Timely delivery during the war: door-to-door delivery timelines were extended, and new timelines were kept.
Retention of highly qualified operational and support staff: providing the utmost care and dedication.
Solutions for critical, medical products: all types of operations to be processed – imports, storage, distribution, returns management, and destruction.
Clinical Trials Logistics Success Stories
Importation of Investigational Medicinal Products (IMPs)
The importation of IMPs comes from different countries in Europe, US, APAC. For example, If IMPs are imported from Europe, they are shipped to Poland which has now become one of the most popular destinations since the conflict. IMPs are then consolidated and transported to the border for customs clearance before onward shipping to the central depot. The transportation duration ranges from 6-10 days depending on the continent of departure. The inbound operational KPIs in the depot remain unchanged.
Export of Biosamples:
The safe storage and rapid delivery of biosamples is essential to ensure sample integrity and prevent degradation. Export of biosamples remains feasible with the shortest delivery timeline from Ukraine to Europe of 48 hours.
Ambient:
48 hours to EU and UK
72-120 hours to USA
Frozen:
48-72 hours to EU
72-96 hours to the UK
96-120 hours to the USA
Minimising Risk and Maximising Safety:
Back up storage in the western part of Ukraine
Quality and operational compliance
Cold-chain support
24/7 temperature monitoring
Energy independence: back-up diesel generators and fuel storage
Trained, qualified operational staff with global support solutions
Connectivity: Starlink, clients, systems
The safety of samples and smooth and uninterrupted running of operations is paramount. With the risk of power failures, we had to take action to ensure that our operations remained uninterrupted. To achieve this, we installed additional back-up diesel generators which were capable of duplicating our current energy provision. A 30-day fuel storage supply has been put in place to support the distribution function.
Measures have been taken to maximize the safety of goods storage. To diversify risks a GDP-compliant facility was set-up as a back-up in the western region of Ukraine. Quality and operational compliance are paramount and cold chain safety is assured via 24/7 live temperature monitoring.
Staying connected at all times was a key focus of our business continuity plan. We had to ensure stable and reliable internet provision and systems access connectivity. This involved extra backup solutions being put in place with internet providers along with additional fiber optics solutions to ensure that we remained in contact with our clients and clinical sites.
Over the last 16 months, we have distributed essential, investigated medicinal products to clinical sites and have also secured the delivery of essential medicines to front-line hospitals. Thanks to the rapid response and dedication of our highly qualified operational and support teams, we have managed to provide successful solutions to ensure that patients continue to get access to innovative and life-enhancing treatments.