Oximio Ukraine: Leading the Way in Clinical Trial Supply Chain Solutions During the War
Despite the ongoing war in Ukraine, the need for clinical trials remains critical. In 2024 alone, from January to October, 46 new studies received approval, with 40 of them being multinational collaborations and six local initiatives. This resilience highlights the essential role of clinical research in advancing healthcare.
Established in 2004, Oximio, Ukraine has a profound understanding of patient care and the complexities of the clinical trial landscape. We are proud to have positioned ourselves as a leader in the industry, currently supporting over 62% of the new studies approved this year. Our success is rooted in our commitment to continuity and adaptability, especially in these challenging times.
Navigating Challenges with Robust Planning
Thanks to comprehensive business continuity plans that ensure uninterrupted operations and the safety of our personnel we have continued to provide agile logistics solutions for sponsors and CROs within the country. Key strategies include:
Availability and Security of Warehouse Staff
The safety and availability of our warehouse personnel are paramount. We have constructed an anti-attack shelter adjacent to our warehouse to protect our team and ensure they can carry out their daily tasks without disruption.
Reliable Power Supplies
Our facilities are equipped with two high-power diesel generators that maintain electricity in all temperature-controlled areas, including refrigerators and freezers. Regular maintenance and testing have ensured these systems function without issues, and we maintain an adequate fuel supply for uninterrupted operations.
Backup Heating Solutions
To safeguard the integrity of our temperature-sensitive materials, our depots are fitted with alternative heating solutions that operate independently of gas supplies. The ventilation system at our Krushynka depot has been modernized, and we have implemented an additional independent electric heating system connected to our generators. Meanwhile, our Brody depot features a solid fuel heating system, ensuring we can maintain optimal conditions year-round.
Distribution Availability
We have secured ongoing fuel supplies through contracts with leading gas stations and have established a three-week fuel storage supporting the uninterupted completion of all deliveries.
Robust Communication Systems
To ensure seamless communication and coordination, our action plan includes provisions for internet connectivity disruptions. We have established connections with two internet providers, alongside backup satellite and fiber optic systems, ensuring we stay connected with our clients and partners globally.
A Commitment to Patient Care
At Oximio, our core values revolve around the safety of our staff and the delivery of patient care. We understand that the stakes are high in clinical trials, and our commitment to excellence drives us to adapt and innovate continuously. The ongoing conflict in Ukraine has posed many challenges, but it has also reinforced our resolve to support vital clinical research initiatives.
As we look to the future, we remain dedicated to providing unparalleled supply chain solutions for clinical trials, ensuring that the essential work of advancing healthcare continues, even in the face of adversity. Our international team, combined with our robust operational strategies, position us as a trusted partner in the global clinical research community.
Together, we are navigating these challenging times with resilience and purpose, ensuring that patient care remains at the heart of everything we do.
Clinical Trial Supply Chain Solutions Ukraine
If you are seeking support for your clinical trial within Ukraine, view our comprehensive supply chain solutions or contact us. Offering agile and tailor-made solutions, we would welcome the opportunity to discuss your unique requirements.
Case Study: Efficient Import, Storage, and Distribution of Diagnostic TB Kits for Research Study in Sub-Saharan Africa
Background & Challenge
Oximio recently received a call from a team of researchers in sub-Saharan Africa in urgent need of help for the import, storage, and distribution of diagnostic kits and medical devices to multiple study sites across the region. They were undertaking a study on tuberculosis (TB) which aimed to improve patient diagnostics in underserved areas. The trial involved sensitive diagnostic kits with strict temperature control ranging from frozen to ultra-low temperatures.
The challenge was to ensure that the diagnostic kits arrived at four study sites in Tanzania and Uganda in a timely manner, within the required temperature ranges, and ready for immediate use in patient diagnostics. Additionally, managing the customs processes and logistics across multiple countries, while maintaining regulatory compliance and minimising delays, was critical to the study’s success.
Solution: Streamlined Logistics and Temperature Control
To meet the demanding logistics requirements Oximio devised an efficient strategy that addressed both the regulatory complexities and the need for strict temperature control during storage and transit.
- Importation and Customs Clearance: Oximio coordinated the Import of Record (IoR) and cleared three bulk shipments through Jomo Kenyatta International Airport (NBO) in Nairobi, Kenya utilising our customs bonded warehouse near Nairobi to receive and store the shipments securely. The strategic location of our warehouse meant it was well placed to support the subsequent distribution to the study sites.
- Storage and Temperature Control: The diagnostic kits required careful storage under specific temperature conditions, ranging from -20°C to -80°C, in addition to dry ice replenishment. Oximio ensured that the equipment was stored in the appropriate temperature-controlled environments within the bonded warehouse. To maintain the integrity of the kits, we partnered with a local carrier specialising in temperature-sensitive goods for regional distribution.
- Regional Distribution: Acting as the Exporter of Record (EoR), we facilitated the distribution of 12 outbound shipments of diagnostic kits to four research sites in Tanzania and Uganda. This included handling the IOR for the goods into the receiving countries and ensuring that each shipment was appropriately packaged for transport at the required temperatures, with dry ice replenishment when necessary.
- Rapid Delivery: Oximio’s efficient logistics network ensured that the diagnostic kits reached the study sites within 72 hours—substantially reducing the standard delivery time from 6 days (if shipped directly from the UK) to just 3 days.
- Swift Regulatory Compliance: The complex process of securing Importation of Record (IoR) permits for each country was conducted in 7 days, half of the usual 14+ days it would normally take. This expedited the entire logistics process, avoiding any unnecessary delays.
Results
The complete logistics process—from importation to final delivery—was executed smoothly. The shipments arrived at the designated study sites in Tanzania and Uganda on time and within the required temperature range, ensuring the diagnostic kits were ready for use in patient diagnostics without compromising their efficacy.
The research team was able to begin their diagnostic procedures as planned, avoiding any disruptions to their study timeline. Additionally, Oximio is now poised to handle site returns and perform reconciliation and destruction of expired or used kits in compliance with the study’s protocols.
Conclusion
Oximio successfully navigated the complexities of international shipping, temperature-sensitive transport, and regulatory compliance to deliver critical diagnostic kits for a TB research study in sub-Saharan Africa. The use of our customs bonded warehouse for storage and regional distribution not only streamlined the process but also saved valuable time, ensuring that the study’s diagnostic efforts were not hindered by logistics challenges.
This case highlights the importance of local knowledge, efficient customs handling, and temperature-controlled logistics in supporting global health initiatives in remote and challenging environments. Through careful planning and strategic partnerships, we were able to deliver results that directly supported the health and research outcomes of the TB study, ensuring timely diagnostics and contributing to the fight against tuberculosis in sub-Saharan Africa.
Oximio sub-Saharan Africa
For further information on our clinical trial supply chain solutions in sub-Saharan Africa, please contact us. We’d be delighted to discuss your project requirements.
Clinical trials in Ukraine: a first-hand perspective
In this update on conducting clinical trials in Ukraine during the war we review:
A country under martial law: operating during the war and what this means for clinical trials
The impact of the war on the clinical trials market: data and anecdotal evidence
Oximio in Ukraine: our people, operations and the services we can solution
Working in partnership to prioritise patient care: Adaptability of service, prioritising shipments, factors influencing cost to serve
A case study: How alternative solutioning has enabled patients to continue on trials
The logistics of extending the footprint of advanced therapy trials
Cell and gene therapy innovators are scaling up and out to reach more patients. Clinical Trials Arena spoke to the team at Oximio (formerly the SMO Group) to discuss market developments.
Most advanced therapy medicinal products (ATMPs, also known as cell and gene therapies) address the clinical needs of “orphan” diseases (very rare conditions, where patients are so thinly spread globally that in some markets it becomes difficult or uneconomical to deliver treatments). Because of this, there are advantages to running trials across additional markets, providing access to more of the right patients.
ATMP studies have typically been designed to bring patients to a designated dosing facility, meaning they were likely to have treatment in the country where a clinical trial was running, close to where the drug was manufactured. However, therapy innovators are increasingly considering how to scale-up, run multi-country trials and bring therapies to patients, giving the opportunity for a wider group to access treatment.
Focus on geography
The US continues to be the industry front runner, with nearly half (550) of all 1,220 global ATMP trials ongoing in 2020[1]. Studies initiated in Europe have remained flat year-on-year, from 2014 to 2018, but we see evidence of the emergence of multi-country trials in the region[2].
Highly complex logistics
A major factor for selecting a clinical trial site or country are the expertise and skills of the clinical centers and healthcare professionals, followed closely by the speed of approval by regulatory authorities in country.
Logistics planning and stakeholder coordination is also a critical factor in ensuring the success of advanced therapy trials. ATMP supply chains are complex, and logistics is the element that is relatively immature, given the diversity of ATMP starting materials and the final product.
ATMPs have a variety of manufacturing strategies (centralized vs decentralized), various product characteristics (autologous vs allogeneic, fresh versus frozen) and different clinical utilizations (out-patient vs in-patient, surgical vs non-surgical). This means that bespoke logistics schemes must be created, considering specific drug characteristics, geographical coverage and the regulatory landscape.
Case study: Bespoke ATMP supply chain in action
The challenge
A developer created an allogenic cell therapy to be shipped fresh from the manufacturing site in in the EU to clinical centers in Israel. Timing was the main challenge – temperature-controlled shipping (15-25°C) for the product, across the ocean and into a patient within 72 hours. To add to the complexity, the administration was not an infusion, but surgery.
Documentation requirements were stringent too and included:
- Certificate of analysis (CoA) – to acknowledge the quality assurance for each batch produced
- Drug pedigree documents – to account for the product as it passes from manufacturer through to the eventual user
A QP release would normally be evaluated post manufacture, but ahead of the trial. The product could be held in safe controlled storage while the evaluation was completed, but that wasn’t possible with a 72-hour shelf life.
There were number of supply chain stakeholders too; the manufacturer in the EU, international transport with import and customs teams, the local delivery teams, those receiving the goods, the pharmacy and the dispensing personnel, plus a team of doctors ready to perform surgery, all of whom needed to play their part within a 36 hour window.
According to Samuel Gal Alterovich, director of strategic services and alliances at Oximio, their role was to act as a “professional integrator” between these parties. “You need a strong team of people who are knowledgeable about the challenges of clinical trial regulations in general and then specifically in the market concerned (in this case, Israel),” Alterovich explains. “But you also need someone knowledgeable about logistics, who is also able to advise on the pharmacy side and be able to prove cold chain GMP-compliant activity.”
The solution
Oximio drafted a clear standard operating procedure including the manufacturer, the global courier, the CRO and the local medical team. “We came up with a protocol in which the roles of each of the parties was very clearly articulated and so it was very clear who needed to do what and when. It all had to go like clockwork,” says Alterovich.
To make it possible, normally sequential processes had to happen in parallel. As soon as the drug was manufactured, the QP and pharmacist were ready to receive the CoA. They reviewed it while the product was on its way. And those documents – CoA and pedigree – were reviewed in real time, so any problems could be communicated, and action taken.
Upon arrival in Israel, a dedicated import team made sure the shipment was covered, that authorities were aware of it, and that the release needed to be hassle-free.
Then came the last-mile delivery, where the Oximio team was on hand to work with the local clinicians to create a GMP-like environment in the medical facility.
The result
Oximio developed tightly focused schemes to ensure that the product reached the patient in the same condition it reached the manufacturing facility, resulting in nearly 30 treatments delivered safely and on time to patients in Israel, with many more expected as the project continues.
Extending the footprint of advanced therapy logistics trials
Oximio’s capability to extend ATMP trials means partners benefit from local expertise and knowledge, including that of regulatory frameworks and culture, to facilitate improved patient access. This ability to interact with the key players in a wide range of territories, including regulators, highlights one of Oximio’s strengths – its network of local market experts. This, combined with dedicated project management in every market, makes Oximio well placed to support ATMP trials in established locations, as well as across a network of smaller, less developed markets.
Whether it’s bringing patients to advanced therapies, or bringing therapies to patients – through the establishment of additional dosing centers and communication with regulatory authorities, to the training of site staff, as well as support at import, export, domestic distribution, storage, and arrival stages – Oximio can build supply chain strategies for the success of your ATMP trial.
[1] The Alliance for Regenerative Medicine, accessed 02/09/21: http://alliancerm.org/wp-content/uploads/2021/03/ARM_AR2020_FINAL-PDF.pdf
[2] The Alliance for Regenerative Medicine, accessed 02/09/21: http://alliancerm.org/wp-content/uploads/2019/10/Trends-in-Clinical-Trials-2019-Final_Digital.pdf
Oximio’s Rapid Response: Vital Medicine Delivered from US to Africa
The need to bridge the gap between essential medicines and their accessibility can mean the difference between success and failure for any clinical trial. This was the problem that faced a local medical facility in South Africa when multiple pallets of vital supplies needed door to door delivery from the US at record speed.
After a cry for help, the logistics team at Oximio, Africa, jumped into action. Liaising with their freight contractor, they were quickly able to negotiate a fee, within a grant funded budget, for their client for airfreight, screening and airline handling. Oximio swiftly arranged collection of 17 pallets from the US supplier depot and within 24 hours, port health authorities had inspected and approved the goods for shipping on an express flight the next day. A controlled room temperature shipment, on arrival in Africa, our teams were waiting to collect and deliver the goods in record time to our customer’s premises. The whole process from start to finish took 5 days.
A job well done; the timely delivery of the medicine was greatly appreciated by our customer. This meant that the progression of their trial could continue as planned with patients receiving their essential treatment without disruption.
A huge thanks to everyone involved.
Oximio’s Clinical Trial Services
With dedicated project managers, bonded depots and warehouses across the globe, find out how we can support you with your clinical trials. Simply contact us. We’re here to help.
Optimising Procurement Costs for Vital Vaccine Supply & Delivery from EU to Africa for US Client
Access to vital medication forms a key part of any clinical trial. The timely and efficient delivery of such medication is essential to ensure the progression of the study and the ongoing development of life-saving treatments. Ensuring that medications reach their destination safely, securely, and cost-effectively is a key priority for any clinical trial and is not without its challenges, particularly when time is of the essence.
In this case study we highlight how Oximio successfully navigated these challenges, ensuring the sourcing and delivery of a critical vaccine comparator for a US-based client who needed to get swift delivery to a trial in South Africa.
Project Request
Our sponsors request required the sourcing and delivery of a large, single batch, of 1,300 comparator vaccine vials from Europe to South Africa. The goal was to optimise costs while streamlining the supply chain, ensuring that the product was delivered in full quantity, correctly labelled, and within the necessary temperature-controlled environment. The supply chain’s complexity was heightened by the requirement to manage multiple international borders, maintain cold chain integrity, and adhere to strict documentation protocols.
Key Challenges
Several challenges were encountered during the project, each requiring careful planning and execution:
Large Quantity in a Single Batch: Sourcing 1,300 vials of the vaccine comparator from a single batch within the European Union posed a significant challenge. Ensuring that the entire batch met the quality standards and was available for immediate dispatch was crucial.
International Coordination: The project required meticulous coordination between a US client, European suppliers, a labelling depot in Georgia, and logistics operators in South Africa and Ghana. Each party played a critical role in the successful execution of the supply chain.
Cold Chain Compliance: Maintaining a consistent temperature of 2-8°C throughout the entire journey was essential to preserve the integrity of the vaccine comparator.
Complex Documentation: The project demanded the precise management of paperwork across four entities – the supplier, Georgian labelling depot, logistics operator, and the end client. Essential documentation included the Contract of Affreightment (CoA), which is not always readily available, and cold chain compliance documentation for both Georgia and South Africa.
Time Sensitivity: The study was already in progress, requiring the medication to be delivered within a limited timeline to avoid delays in the clinical trial.
Cost Optimisation: The client required a cost-effective solution that did not compromise on quality or timelines. The decision to source from the EU rather than the US played a pivotal role in reducing overall costs.
Supply Chain Execution
To address these challenges, a multi-step supply chain strategy was developed and executed:
Sourcing and Collection: Our EU vendor, based in Lithuania, sourced the vaccine comparator from a partner in Romania. The product was collected and prepared for export.
Export and Cold Chain Management: The stock was exported from Europe, ensuring that the product was maintained within the required temperature range during transport to our facility in Georgia. The delivery was made under Delivered at Place (DAP) Incoterms 2010, ensuring that the seller took responsibility for delivering the goods to a specified location in Georgia.
Labelling and Documentation: Once the product arrived in Georgia, Oximio was responsible for importing the product, verifying the supply, and arranging for the necessary labelling. The product was then prepared for export under Free Carrier (FCA) Incoterms 2010, meaning that the buyer assumed responsibility once the goods were handed over to the carrier.
Logistics to Ghana: From here the labelled stock was collected by courier from our Georgian depot with goods transportation manged to the end client’s facility in Ghana where they were responsible for the final importation.
Outcome
The project was completed successfully, with the product delivered on time and at half the cost of sourcing from the US. Despite the complexities involved, including maintaining the cold chain across multiple borders and coordinating documentation between four different entities, the client received the full quantity of vaccine comparator needed to proceed with the study. This efficient and cost-effective solution not only met their requirements but also demonstrated our ability to manage complex global supply chains with precision.
Clinical Trial Supply Chain Solutions from Oximio
The project showcases the intricate coordination and strategic sourcing required to meet the demanding timelines and rigorous standards of clinical trials. By leveraging a strategic sourcing approach, maintaining rigorous cold chain standards, and ensuring meticulous coordination across multiple stakeholders we were delighted to deliver a successful outcome for our delighted client.
To find out how our supply chain solutions, can support your clinical research, please contact us.
36 Hour Sourcing and Delivery of Critical Chemotherapy Medication in Serbia
Clinical trials play a pivotal role in the ongoing battle against cancer. These trials are essential for discovering new treatments, understanding the efficacy and safety of emerging therapies, and ultimately finding cures for various types of cancer. They are complex, time-sensitive operations that often require the collaboration of multiple stakeholders, including research organisations, healthcare providers, pharmaceutical companies, and logistics partners. The success of these trials—and the well-being of the patients involved—depends on the seamless coordination and timely delivery of treatments.
In this case study, we highlight the crucial role that our Serbian team played in the urgent sourcing and delivery of vital oncology medication to a patient in hospital within the country.
Urgent CRO Request for Oncology Drugs
Late one night our Serbian team received an urgent request from a leading Clinical Research Organisation (CRO) which was faced with a critical situation that required a speedy solution. They urgently needed two packs of chemotherapy medication which had to be sourced and delivered to a patient in a hospital in the country within 36 hours. The stakes were high. Any delay in the delivery could jeopardise the patient’s treatment and overall outcome of the trial.
The Challenge
The task presented a series of logistical challenges. First, the chemotherapy medication had to be sourced from a wholesaler, which typically involves navigating regulatory hurdles, coordinating with suppliers, and managing documentation. Second, the medication needed to be transported swiftly and securely from the wholesaler to a designated pharmacy, and then collected from the pharmacy by Oximio’s dedicated courier and delivered to the hospital.
Time was of the essence. Quick delivery to the patient was the number one priority. Legal and payment terms, which are crucial in such transactions, had to take second place. Oximio needed to design a solution that was both efficient and reliable, ensuring that every step in the process was executed flawlessly.
The Solution
Oximio responded to the CRO’s urgent request with immediate action. The team quickly ordered the chemotherapy medication from a reliable wholesaler and coordinated with the pharmacy to ensure that the drugs would be ready for pickup as soon as possible. Understanding the critical nature of the situation, Oximio devised a streamlined scheme and document flow to expedite the process.
Key to the success of this operation was Oximio’s ability to prioritise the outcome – getting the medication to the patient. This meant focusing on what was necessary to make the delivery happen on time, rather than getting caught up in standard procedures that could slow down the process.
A courier was swiftly dispatched to collect the medication from the pharmacy. Throughout the journey, Oximio maintained close communication with all parties involved, ensuring that the shipment was on track and that any potential issues were addressed immediately. The entire operation was executed with precision, from sourcing the medication to delivering it to the hospital in Serbia, all within the critical 36-hour window.
The Result: Essential Medication Delivered on Time
The chemotherapy medication was delivered to the hospital in Serbia within the required timeframe. The quick and effective response by Oximio ensured that the patient received the necessary treatment without delay, much to the relief of the attending medical team. The doctor who received the medication was very grateful and delighted with the timely delivery.
Highlighting the importance of reliable logistics in critical healthcare situations, this case demonstrates the vital role that logistics partners play in the success of clinical trials and the broader healthcare industry. Oximio’s ability to act swiftly and decisively in the face of a challenging situation not only helped to meet the immediate needs of the patient but also reinforced the importance of agility in the delivery of healthcare solutions.
Clinical Trial Logistics Services in Serbia
With a licenced warehouse and wholly owned courier fleet, Oximio offers a comprehensive range of storage and distribution services form our Belgrade facility. To find out how we can support your clinical study, please contact us. We look forward to discussing your requirements.
Delivering vital biospecimens from Ukraine to Europe in record time
For those living with a life threatening or altering disease, the quick and effective analysis of a biospecimen may be their last chance of identifying a cure or treatment. At times like this, the swift and secure transportation of such samples takes centre stage.
In this case study, we showcase the rapid response of Oximio’s logistics operations team in Ukraine as they expedited the delivery of critical biospecimens to European destinations.
The Challenge:
Oximio receives a short notice request for the urgent delivery of three biospecimens to be shipped safely and securely from Ukraine to three locations in Europe: UK, Switzerland and Belgium. It was vital that each sample was delivered to its end destination within a tight 72 hour timeline. In addition to this, the samples had to be kept at a temperature of between 15°C and 25°C throughout the journey.
Execution:
The team at Oximio, Ukraine, quickly prepared a detailed plan which considered the most efficient transport routes, regulatory requirements, customs protocols and the essential temperature requirements. Each biospecimen was carefully packaged and placed in a temperature-controlled container. Thanks to the team’s experience and expertise, they were able to ensure a seamless process from start to finish.
Successful Outcome:
Not only did the team exceed the expected requirements with the safe delivery of all samples within the stipulated 72-hour window, some of the goods reached their destination within a record 48 hours. Having transported the samples at the required temperatures, this meant that their integrity was assured and they were fit for analysis.
Oximio’s achievement highlighted the importance of rapid, reliable and compliant transportation in a critical medical situation. The project emphasised the interaction between meticulous planning, implementation and expert knowledge of geographical nuances, regulatory requirements and logistic hurdles.
“The war in Ukraine has impacted many things, but there is still a huge portfolio of ongoing clinical trials within the country. While there is no air transportation, there are logistics on the ground. So, we’ve utilised that as a solution and been able to manage the export of biospecimens from Ukraine to Europe,” says Zayheda Khan, chief commercial officer at Oximio.
“We are a leader in the export of biospecimen solutions from Ukraine, especially since the war started. It has been on our radar. It shows that when there is a challenge, Oximio creates a solution.”
Biospecimen Storage & Distribution Solutions from Oximio
Oximio stands at the forefront of the logistics and transportation industry, specialising in satisfying the needs of the worldwide clinical trials sector. With an extensive global presence, the company delivers a diverse array of services meticulously crafted to address the specific needs of each customer and meet the challenges often encountered in clinical trials and medical research.
Operating across six continents, Oximio’s far-reaching network ensures the seamless provision of logistics solutions for international clinical trials, guaranteeing the safe and optimal delivery of biospecimens to their designated destinations.
To find out how we can support your biospecimen logistic requirements, simply contact us.