Oximio in Serbia – A Gateway to Clinical Trials in Europe
Hello and a warm welcome to Oximio’s new podcast series exploring the world of clinical trials, how trials are run across the globe and highlighting some of the aspects that are involved when it comes to dealing with logistics.
We all realise and appreciate the importance of clinical research for developing new medications and treatments. However, navigating the complex world of international research can be daunting. In the first of our series, we are focusing on Serbia. Thanks to its efforts to further strengthen and enhance its well-established clinical research sector, Serbia is rising as a reliable and efficient location. This dynamic nation offers a wealth of advantages for pharmaceutical companies and research institutions.
Hi, I’m Alison, Communications Specialist at Oximio, and today I’m joined by Lana Latinovic, Oximio’s Depot and Business Development Manager for Serbia. Lana is going to tell us more about the conducting of trials in the country, shining a light on the principal reasons for the country’s rising status.
Transcript
Q: Hi Lana. Thanks so much for joining us today. To start, it would be good to know what some of the key factors are that make Serbia so attractive for clinical trials? Perhaps you can give us some background information on this.
A: There are several reasons, but a few of the big ones are cost-effectiveness, regulations, and the patient population. Compared to other European countries, Serbia offers significant cost savings. At the same time, they’ve been working hard to streamline their regulatory framework to align with the EU. This makes it much easier for companies to conduct trials in Serbia, ensuring compliance with international requirements. Plus, Serbia has a diverse patient population of over 6 million people. This provides researchers with access to a wider range of genetic backgrounds and medical conditions, which can significantly enhance the representation of their studies.
Q: Yes. Streamlined regulations and a diverse patient pool are huge advantages. Can you elaborate on how Serbia’s approach to regulations benefits clinical trials?
A: Definitely. By aligning their regulations with the EU, Serbia makes it much easier for companies to conduct trials there. It ensures compliance with international standards and helps to avoid any roadblocks. Another benefit is the faster turnaround time for approvals. The typical application review process takes between 15 – 90 days depending on whether it’s an import or export license or a licence from the Ministry of health which is approximately 90 days., which is significantly quicker than in some other locations.
Q: That’s very encouraging about the quick review process. Touching again on the diverse patient population, how exactly does that benefit clinical trials and indeed patients themselves?
A: It benefits trials in a couple of ways. With over 6 million people, Serbia offers a large pool of potential participants. But more importantly, the population is diverse. This means researchers can access a wider range of genetic backgrounds and medical conditions. This is crucial for ensuring their studies are representative of the broader population the treatment is intended for. There’s also another interesting aspect. Because some medications may not be readily available through state-funded programs, participation in a clinical trial can give patients access to these potentially life-saving treatments. Access to novel treatments is an incentive for patients and help improve recruitment efforts and shorten trial timelines.
Q: Yes, that’s a great point about patient motivation and access to new treatments. Can you tell us about those people conducting the trials, the level of expertise available and how this impacts the trials?
A: Serbia boasts a well-educated and highly trained workforce specifically for clinical research. These professionals, including investigators and site staff, are qualified to deliver high-quality clinical trial data following GxP guidelines. This expertise, combined with a strong patient-centric approach, ensures that studies run smoothly and meet the highest international standards.
Q: Yes, having a qualified workforce is absolutely critical. This rather conveniently leads us into Oximio’s role as a clinical supply chain provider. Perhaps you can tell us about Oximio itself, in Serbia. How do your services benefit sponsors running clinical trials within the country?
A: Oximio’s Serbian facility, located strategically in Belgrade, acts as a gateway to the Balkans, Asia, and Western Europe. We have a global reach supported by a vast distribution network. Our facility offers 277.41 square meters of storage space, with temperature-controlled zones ranging from non-controlled ambient to ultra-low freezers. We can store biological goods including blood products or derivative, antibiotics, Cytotoxic and also controlled drugs on request.
We are supported with WHL Licences and ISO 9001: 2015 certification. We provide end-to-end clinical trial logistic services, including competitive comparator sourcing, all in line with GDP best practices. We can offer competitive pricing.
Thank you so much Lana for this very informative insight and useful overview of Oximio’s own facilities in Serbia. I think we can all agree that there are many advantages to running a clinical trial within the country.
Lana: It’s been a pleasure.
Explore Oximio’s Clinical Trial Services in Serbia.