Mykola Nikolaiev, Oximio CEO, Insight into Clinical Trials
We are thrilled to have the opportunity to talk to Mykola Nikolaiev, who took on the role of Oximio’s CEO in December 2022. It has been six months since he took on this position, and we are eager to hear his insights on the primary challenges within the clinical trials logistics field and how Oximio is not only actively tackling them, but making significant advancements.
With the increasing globalization of clinical trials, how does Oximio address the challenges of managing logistics across different regions and countries?
We tackle these through a comprehensive approach, building up expertise and establishing a robust framework supported by legal structures that facilitate growth and prepare for expansion. We actively work on building connections and expanding our depots to ensure efficient logistics management across various regions.
Our employees are at the heart of everything we do. We recognize the importance of investing in our staff and growing their expertise and skills. We understand that having a skilled workforce is essential for navigating the complexities of global clinical trial logistics.
Oximio benefits from exceptional knowledge of local and global standards, enabling us to adapt our logistics processes to meet the requirements and regulations of different regions, while ensuring compliance with international standards. This combination of expertise, framework development, investment in talent, and understanding of local and global standards allows us to effectively address the challenges associated with managing logistics in a global clinical trial environment.
How do you leverage technology and data analytics to optimize the logistics processes in clinical trials?
Oximio benefits from interlinked IT systems which gives us the ability to access, in real time, stock levels and stock movement from a central point. We maintain centralized control for all product data which we handle, including storage, transportation, and all other operations. Our IT-enabled business processes are in full compliance with and support the implementation of our QMS documents, minimizing the risk of errors. In some locations, we have the capability to scan barcodes on packages upon delivery using a smartphone app, with this information being immediately updated in our information systems. This globality of operational data means that a Project Manager in any our locations, can manage projects worldwide and is able to take quick action in the confidence that the information is accurate.
Our customers also benefit from our convenient online portal, Oximio Online, which streamlines project activities. This is currently being upgraded to improve and provide immediate access to all project information at the touch of a button 24/7, including an API for interface from us to link to customer information systems.
Technology moves at a rapid pace, and we are always seeking ways to improve efficiencies that will lead to new innovative business opportunities.
Patient-centricity has become a significant focus in clinical trials. How does Oximio adapt its logistics services to meet the needs of patients, while ensuring efficiency and compliance?
We pride ourselves in providing tailor-made solutions. This approach ensures that the logistics services provided are customized and aligned with the specific requirements of patients.
We believe in making things as easy as possible for patients. One area is the direct-to-patient approach. In some instances, we have gone that extra step by successfully implementing this strategy in high-risk environments. By streamlining the logistics process, we also greatly minimize the burden on patients which enhances their overall experience when enrolled on a clinical trial.
We operate in complex and sometimes difficult regulatory environments and fully understand the importance of compliance. Where we can, we will lobby to try and find solutions that meet the specific needs of patient sponsors. This could be addressing challenges related to importation and the regulatory environment, ensuring that all logistics services comply with relevant regulations.
By combining tailor-made solutions, simplification of processes, and a proactive approach to regulatory challenges, we meet the needs of patients in clinical trials while maintaining efficiency and compliance.
We recently had our first home healthcare visit in Israel which was a great success enabling the nurse to collect the bio-samples from the patient. Once collected, these were transported to the central laboratory facility located in Belgium for testing. Our client had been experiencing some logistical challenges but we were able to speedily organise a suitable and complete solution to collect the bio-samples within one hour of request and transport them onto the final destination.
What strategies do you employ to ensure timely and secure transportation of sensitive materials, such as investigational drugs, biological samples, or temperature-sensitive supplies, during clinical trials?
We very much have a hands-on approach with the emphasis on personal management and oversight throughout the transportation process. Attention to detail is crucial, ensuring that all necessary precautions are taken.
Communication is key with those involved communicating at all stages. We have a variety of IT systems and platforms in place to assist with the movement of sensitive materials with strict controls in place for the secure storage, under lock and key, for controlled substances and scheduled drugs. We benefit from an excellent infrastructure and relevant licenses are maintained, providing an additional service that not everyone can offer.
What sets Oximio apart from competitors in terms of providing innovative and efficient logistics solutions for clinical trials? Can you highlight any success stories or case studies?
What sets us apart is our personalized, tailor-made and innovative solutions to address the complex logistic challenges faced by our clients. Our customers also benefit from dedicated project managers who oversee projects from start to finish. This means we can closely monitor and address any potential issues or bottlenecks, ensuring timely delivery and efficient management of the trial logistics.
We also have a very strong focus on risk management. We understand the critical nature of the trials and the importance of mitigating risks associated with transportation, storage, customs procedures, and regulatory compliance. Our team of experts proactively identify and manages potential risks, ensuring compliance with local regulations and international standards.
We can act swiftly and in an agile manner. We’ve been able to intervene and help customers release products from customs in a number of countries because of local expertise.
Oximio, Ukraine, recently answered three urgent calls for the delivery of bio-samples to separate locations within Europe – Switzerland, Belgium and the UK. It was essential that the samples were transported at ambient temperatures to guarantee their integrity. With temperature-controlled transport solutions capable of maintaining ambient temperatures with a range of +150C – + 250C, this was something the team could easily assist with.
Providing an essential link for clinical trial logistics, not only did they deliver within their quoted 72 hour timeline, they surpassed this with some of the goods being delivered within a record 48 hours.
And recently, in Serbia, we had to deliver to a patient in a very time critical manner and successfully developed the logistics in 8 hours over night.
Compliance with regulatory guidelines is crucial in the clinical trials industry. How does Oximio ensure adherence to relevant regulations and standards when it comes to logistics?
As CEO, I believe it is my overall responsibility to ensure that we as an organisation adhere to all the necessary regulations and standards. This requires active involvement and leadership. At Oximio, we have a strong compliance culture. This starts at the top and our emphasis on the importance of compliance, filters throughout the organization.
We have compliance teams who are responsible for overseeing regulatory compliance matters and they have the relevant authority, resources and expertise to ensure we are doing this effectively. We have policies and procedures in place which are combined with robust auditing and monitoring processes. Risk assessments are carried out to evaluate vulnerabilities such as temperature control, chain of custody, data privacy and correct documentation. Staff receive regular training.
We also encourage reporting and whistleblowing and have mechanisms in place for employees to report any compliance violations or concerns. By creating a culture of transparency and whistleblowers anonymity, we can ensure that any reported issues are promptly investigated and addressed.
We foster collaboration with regulatory agencies, maintain open lines of communication and participate in industry forums or working groups. We only engage qualified logistics partners who have a strong track record of compliance and possess the necessary certifications.
Of course, staying informed and up to date with the regulatory landscape and monitoring changes ensures we comply with industry best practices. We are continuously seeking opportunities for improvement and are committed to finding efficient solutions to deliver outstanding results to our clients.