Oximio Ukraine Recognised by Ministry of Health as a Critical Company to National Healthcare During Wartime
Oximio Ukraine is honoured to share that, as of January 2025, the Ministry of Health of Ukraine has officially recognized our role as critical to the national healthcare sector during wartime. This acknowledgment reflects Oximio Ukraine’s essential role in supporting and strengthening the country’s healthcare system in these challenging times.
To secure this recognition, we underwent a comprehensive evaluation process to demonstrate our vital contribution to Ukraine’s medical infrastructure.
This status enhances Oximio Ukraine’s business continuity capabilities during these challenging times. This recognition not only reinforces Oximio Ukraine’s local presence but also highlights the resilience of our entire global Group, as many global roles are based in Ukraine.
“We worked a lot to receive this status from the Ministry of Health,” said Olga Vizgalova, Managing Director of Oximio in Ukraine and Regional Director for Central Eastern Europe. “It is a reflection of the hard work and dedication of our entire team, whose commitment to excellence has enabled us to continue supporting Ukraine’s healthcare system and economy. This achievement strengthens our resolve to ensure the health and well-being of those who depend on us during these challenging times.”
We extend our heartfelt gratitude to all who contributed to this milestone. Their unwavering efforts make a meaningful impact within the company and in the broader healthcare landscape of Ukraine.
For further information on our clinical trial supply chain solutions in Ukraine, please view our website: https://oximio.com/network/ukraine/
Best Price and Shortest Lead Times for Avastin® from Ukraine and Georgia
According to Global Data oncology continues to dominate the clinical trial landscape in 2025. Avastin® (Bevacizumab) remains at the forefront in the treatment of a variety of cancers.
We are pleased to be able to offer Avastin® for clinical trials from Georgia and Ukraine at the most competitive prices with fast lead times. With our trusted supply chain and ability to provide Avastin® with Certificate of Analysis (CoA) and EU Equivalency, we can support your trial needs efficiently and cost-effectively. Available in 100mg and 400 mg vials, each with a minimum shelf life of 18 months.
If you’re planning a clinical trial and need Avastin®, please don’t hesitate to get in touch for a quotation. We’re here to help you secure the right supplies, exactly when you need them.
Contact us today. We’d be delighted to discuss your requirements.
Kenya Regulatory Update: Mandatory Marine Cargo Insurance from 14 February 2025
A new regulatory requirement for all marine product imports into Kenya will come into effect on 14th February 2025. The Insurance Regulatory Authority (IRA) and the Kenya Revenue Authority (KRA) have jointly announced that all importers must obtain Marine Cargo Insurance from a locally licensed insurer, as per the Insurance Act, CAP 487, Laws of Kenya, before receiving customs clearance.
For our customers, this insurance will be arranged by Oximio and will be a mandatory document for shipping approval. The cost will be included as a Pass Through Cost (PTC), and details for compliance will be communicated.
Below are the key changes that will affect your operations:
- Insurance Changes: With insurance now being provided locally, you will need to review your terms of purchase and engagements with your suppliers to exclude the insurance element in cases where the Incoterms were previously CIF.
- IDF and Marine Insurance Procurement: Marine insurance procurement can only proceed once the Import Declaration Form (IDF) has been completed in KRA’s ICMS system. This form is now a mandatory document and will be used as the key reference point for all certificates going forward. Please ensure to capture the IDF number in your email heading for all marine requests moving forward.
- Additional Transaction Charges: Additional transaction charges may be introduced through the IRA portal, this is still pending confirmation.
- Validity of Existing Marine Certificates: The marine cover notes/certificates issued before 14th February 2024 will no longer be valid for cargo clearance and will need to be recalled. Kindly prepare a list or schedule of marine certificates that are yet to be cleared at the port, so we can notify Mayfair Insurance to have them reissufed on the digital platform.
Oximio in Kenya
Explore our supply chain solutions for clinical trials in Kenya and sub-Saharan Africa.
Israel VAT Rate Changes from 1st January 2025
With effect from January 1, 2025, the VAT rate in Israel will be increased from 17% to 18%.
This change will primarily affect:
- Procurement requests: The updated VAT rate will be applied to all procurement transactions moving forward.
- Monthly invoices for local companies: All invoices issued to local companies will reflect the revised VAT rate.
- Future customs duties payments: Customs duties payments will also be impacted by the VAT increase, leading to adjustments in future calculations.
Clinical trial sponsors and CROs are advised to ensure that their systems are updated accordingly to accommodate this change and avoid any discrepancies.
For further information on our clinical trial supply chain solutions in Israel, why not visit our website or contact us. We’d be happy to discuss your requirements.
New bonded depot in Serbia opens
We are delighted to share that expansion of our global bonded depot network continues. We have successfully received the bonded depot license this week for our Serbia facility.
This opens a route for imports of bulk shipments and distribution from our depot in Serbia to Southeast Europe and Balkan counties with increased efficiency and centralised supply chain governance.
Our clients can save up to 50% in cost in comparison to direct-to-site models, which involve higher costs relating to requirements for multiple deliveries. In addition there are benefits in time delivery efficiency, centralised inventory management and waste minimisation.
Mykola Nikolaiev, Oximio CEO commented “This significant milestone is an important step in reaching greater patient populations in Southeast Europe and together with improving timelines of multinational clinical trials whilst maintaining quality oversight every step of the way”.
Strategic Update on Clinical Trial Material Importation in South Africa
We are pleased to announce significant developments regarding our operations in South Africa, enabling Oximio SA to assume the role of Importer of Record (IoR) for all Clinical Trial Material shipments into the country. This encompasses Investigational Medicinal Products (IMPs), Named Patient Materials, medical devices, and laboratory kits.
Key Takeaways:
- Regulatory Compliance: Oximio SA will be designated in submissions to SAHPRA as the authorized IoR, thereby assuming responsibility for customs clearance and delivery to designated sites or Oximio warehouse, contingent on our agreed scope of services with the client.
- Delegated Authority Framework: We will establish a formal Letter of Delegated Authority between Oximio SA and the Sponsor, detailing the comprehensive logistical responsibilities pertaining to the Clinical Trial. This framework will effectively limit liability concerning ownership of the imported materials.
Customer Benefits:
- Streamlined Transactions: This approach minimizes transactional complexities, significantly reducing the risk of the Sponsor facing erroneous billing or potential double charges, thereby enhancing fiscal clarity.
- VAT Management: Oximio SA will handle local VAT payments, reclaim the full VAT, and will bill clients solely for the Disbursement fee based on 15% VAT of the total shipment value at the pre-agreed PTC rate.
- Centralized Communication: Acting as the sole point of contact for invoice and shipping document review and approval, Oximio SA will facilitate a more efficient shipping process, effectively mitigating delays experienced with previous shipments.
- Financial Relief for Local CROs and Sites: This arrangement alleviates the burden on local CROs and sites from having to pay VAT and duties upfront for DTS shipments, thus reducing the risk of regulatory complications at customs.
Under this new framework, all shipments will be processed under CIP (Carriage and Insurance Paid To) or DAP (Delivered at Place) incoterms:
- CIP: The seller not only covers carriage costs but also secures insurance against loss or damage during transit to the specified destination.
- DAP: The seller assumes full responsibility for the shipment until the goods are delivered to a specified location, with risk transferring to the buyer upon delivery. While the seller manages export clearance, the buyer is accountable for import customs duties, fees, and taxes.
We look forward to leveraging this new structure to enhance our service delivery and client satisfaction.
Clinical Trial Supply Chain Solutions in South Africa
To find out more about how we can support your clinical trial in South Africa, please visit our website or contact us.
The SMO Group announces company name change to Oximio
HUNTINGDON, Cambridgeshire, United Kingdom – 1 March 2021 – The global clinical trial services provider The SMO Group has announced today that the company will begin operating under a new name and will be known henceforth as Oximio, effective immediately. The 18 months extensive rebranding project is a response to the accelerated company growth and a renewal of the company vision.
“By announcing Oximio, we are opening the next chapter in the company’s history. In the past 16 years we have grown to become a truly global company, constantly focusing on further geographical expansion and strengthening our service portfolio. In the past years we put a huge effort into developing a quality led organization, which has resulted in higher patient satisfaction and a wider service coverage.
I believe it was appropriate to rebrand our company to better reflect the fresh and professional mindset of our people and to emphasize the knowledge, expertise and added value we bring to the clinical research market.” – CEO, Krisztina Varga stated. “The new brand will help us seize the opportunity to reinforce our reputation of being a well-established clinical trials services provider, building on our history and our strong company culture. We aim to provide a full brand experience to our clients to help them be more successful in their core business.
We will be working extremely hard to achieve our vision: We are dedicated to expediting research to find effective treatments and cures for all living beings.”
The company’s ownership, staff, and legal entity names remain unchanged. Both names – SMO GROUP® and OXIMIO®, as our registered trademarks will be used within a transition period and thereafter on per case basis.
For more information about the brand change please visit our new website: oximio.com.
Oximio expands its Africa capability with a transit depot in Kenya
The new clinical trial logistics hub reaches research sites in East, Central and West Africa faster and at a reduced cost, compared with established supply chain models
Huntingdon, United Kingdom (March 10, 2022) – Oximio is changing the landscape of clinical trials in sub-Saharan Africa, with its new transit depot near Nairobi. Positioned to serve Kenya and act as a gateway for logistics across East, Central and West Africa, the organisation provides clinical trial material, comparator medicines and ancillary supplies to clinical sites throughout these regions.
Fully operational and licensed from November 2021, Oximio Kenya creates end-to-end supply chain solutions for multinational clinical trials, ultimately attracting more sponsors and new technologies to the region to reach larger patient populations. With its first projects in the start-up phase last month, services extend beyond storage distribution to managing end-to-end processes, from comparator sourcing and courier services to providing country-specific labeling and kit assembly.
Clinical Trial Applicants can now save the Sponsor money on logistics, by utilising their Regulatory Approval to send fewer consolidated exports to Oximio Kenya central warehouse, for rapid redistribution to sites. This permits the direct release of imported consignments to the depot, where customs clearance allows continuous temperature control management.
By authorising Oximio Kenya as Importer of Record (IoR), timescales for the set-up and delivery of clinical studies are ensured through rapid local and cross-border shipments. With optimised courier solutions, research sites are now supplied faster, with minimised temperature excursion risk, consolidated consignments and reduced costs, compared to the traditional direct-to-site model.
Oximio’s depot is located near Limuru, twenty-five minutes away from the Nairobi CBD and two minutes away from the road linking Nairobi with the country’s west. Oximio’s sub-Saharan Africa managing director, Rob van den Bergh said: “Our focus is to provide best-in-class supply chain solutions to increase efficiency, lower the research cost per patient and ultimately attract more sponsors, thereby offering a wider spectrum of clinical research into all regions.”
The newly commissioned warehouse is designed to meet international standards to house Oximio’s leading cold-chain operations. It is compliant with GxP regulation and designed to provide storage for temperature ranges including +15 to +25°C, +2 to +8°C, -15 to -25°C and -80°C. The facility is licensed to store investigational medicine, medical devices, commercial medicines, ancillaries and other PPB-approved drugs.
“The clinical trial industry is one of the most heavily regulated, and Oximio is the only company providing clinical trial logistics support as a one-stop-shop for the sub-Saharan Africa continent via our local depot in Pretoria, South Africa, a partner depot in Egypt and now, our transit customs depot in Kenya,” added van den Bergh.
Oximio Group CEO Krisztina Varga added: “Our intention is to team up with sponsors, CROs and CMOs, and together create opportunities to enable more clinical trials in the regions. This is a key differentiator and elevates the patient focus in sub-Saharan Africa.”
Originally published on Pharmaceutical Technology.
Mykola Nikolaiev appointed Chief Executive Officer
Following the announcement of 8th December 2022, the Board of Oximio confirms the appointment of Mykola Nikolaiev as the new Chief Executive Officer (CEO).
Accordingly, Krisztina Varga has resigned from the Board as CEO and Mykola Nikolaiev takes over the role as Oximio embarks on its next development phase.
Mrs. Varga has implemented great changes during her time as our CEO. Under her leadership she has brought international management standards with a multicultural and diverse mindset to the Company, she has overseen the creation of its brilliant new brand, Oximio and she has put our people at the centre of our growth. We thank Krisztina for her leadership, passion and professionalism over the last 3 years and wish her every success in her new ventures.
Mr. Nikolaiev has an established track record of achieving exceptional business results through a high level of commitment, professional growth, and integrity. He has extensive industry experience and an impressive range of academic qualifications. Most recently, as our Chief Business Officer, he has been pivotal in defining our continuity and transformation strategies in response to the unprecedented change taking place in the clinical trials space.
Alexander Skorobogatko, Chairman of the Shareholders said:
“I am delighted to confirm Mykola’s appointment as our new CEO. He is a truly worthy successor. His achievements in senior management and leadership roles within Oximio over the last seven years are testament to his expertise and skills in navigating complex environments. This, coupled with his ability to create valuable partnerships and guide businesses through major periods of change, means he is well placed to build on the strong foundations already laid.”
Mykola Nikolaiev said:
“I am delighted to accept the Board’s proposal to lead Oximio. In a rapidly changing environment, we must keep the confidence of our customers, employees, and shareholders. Oximio has so many strengths, from our customer focus to the use of smart resources, deep local expertise, commitment to quality, proactive business development, and our big belief in care.
Because of these strengths, we continue to achieve excellent results. I rely on you all as the heart of this company because at Oximio, we are and will always be people who care for people.”
For further information, please contact Communications at communications@oximio.com
Oximio expands patient centricity services in Israel
As Oximio patient centricity services continue to expand, we are delighted to announce that the first home healthcare visit in Israel took place week commencing 9th of January 2023.
The services allow for the nurses to collect the bio-samples from the patients’ home to be transported to the relevant laboratory. To support the transportation of the bio-samples the Oximio team in Israel can provide speedily solutions to deliver the samples to the final destination.
We are proud of our commitment, integrity and awareness as we continue to partner with our clients, support patients and grow Oximio’s role as an international clinical trial services provider.