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We work according to the demands, logistics and regulations of each market around the world.

To get more local information, please click on the country of your interest.

  • Oximio’s Central Depots
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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

Oximio 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.

Oximio Israel excels in securing import licenses for unlicensed medication

We are delighted to announce that Oximio Israel has been successfully awarded yet another import license for Compassionate use program in January 2023.

“Compassionate use” allows for a patient outside of clinical trials with a serious or life-threatening disease to gain access to an investigational medical product including drug, biologic, or medical device when no alternative therapy options are available.

 

There are three scenarios when a patient can get an access to the unlicensed medication:

  1. Compassionate use program: the patient has never taken part in a clinical trial.

  2. Post-trial access: the patient has completed or dropped out of the clinical trial.

  3. Unlicensed supply: when the unregistered medication can be imported for an individual patient.


Oximio Israel has been successfully arranging licences for the above programmes since 2014.

At Oximio we strive to put the patient first and to find solutions to better our patient-centric services to compassionately achieve the best experience and outcome for the person and the family.

Oximio support for Türkiye earthquake disaster

Oximio sends vital aid to Turkiye earthquake victims

The Oximio Community expresses its deepest condolences and supports the communities affected by the earthquake in Türkiye.

We can confirm that our Oximio facility in Türkiye has not been affected, however we feel the pain and understand the devastation caused by this disaster. Our priority and focus is to help with the humanitarian crisis in the region and to provide support where possible on any recovery efforts.

We are here to support with any assistance which may include advice, communications, translations, or any other provisions required for the Türkiye earthquake support. If you experience any challenges in providing aid, please email turkiye.support@oximio.com.

Oximio Ukraine is represented at CTS Executive Board at EBA

We are delighted to announce that Oximio Ukraine is represented at the Clinical Trials Subcommittee (CTS) Executive Board at the European Business Association (EBA).

Established in 1999, the EBA provides a forum in which members can discuss and find solutions to common problems affecting business in Ukraine.  This initiative was initially supported by the European Commission and has grown to become one of the largest and most influential business communities in the country.

There are many subcommittees of the EBA and one of these is the Clinical Trial Services (CTS) subcommittee. The CTS is focused on the conduct of clinical trials in Ukraine and furthermore the harmonisation of the regulatory groups by cooperating with the state health authorities.

Given the importance of various logistical challenges during the war in Ukraine, the CTS Board decided to include an additional member of the Board, a representative of a CTS logistics company. This CTS board member shall discuss and oversee the difficulties of the provision of logistics.

As a result of the voting, Olga Vizgalova, Oximio MD Ukraine, has been chosen as the additional member of the CTS subcommittee Board with a focus on logistics.

Mykola Nikolaiev, CEO of Oximio commented, “This accomplishment demonstrates the recognition and importance of Oximio by the EBA.  This is a great achievement to represent Ukraine and to help the EBA to understand the challenges faced in the clinical trials and health care communities”.

Oximio Ukraine implements business continuity plan in response to war

Oximio is a global end-to-end logistics provider for clinical trials with over 19 years of experience in the industry.

Despite the brutal impacts on our Ukrainian founding country in the past year, this has inspired us to strive to deliver not only for the company but as ambassadors for all the voices of Ukrainian business and communities and the international partnerships and friendships that we forge.

Since the full-scale invasion, Oximio Ukraine was the first clinical trials service provider to resume operations in Ukraine in March 2022.