Running Clinical Trials in Serbia – Quick Facts
Navigating the regulatory landscape and operational requirements for clinical trials in Serbia demands a comprehensive understanding of the local procedures and requirements. In this handy guide, we give a useful overview of essential information to help you with your clinical trial.
From regulatory approval processes to site agreements, language considerations to insurance prerequisites, there are many factors to be considered for efficient trial execution in Serbia. Explore these insights to ensure smooth sailing through the complexities of conducting clinical research in this Balkan nation.
- Site and Investigator Agreements: Negotiations for agreements can commence prior to study approval, although Central Ethics Committee (CEC) approval may for needed for some sights beforehand.
- Local Ethics committee (LEC): The review and approval processes by CEC and Regulatory Agency (RA) of the Ministry of Health (MoH) can run simultaneously.
- Proximity of Trial Sites from Belgrade: All trial sites are situated within a radius of approximately 350 kilometres from the capital
- Legal Requirements: A local, legal entity is mandatory for submission.
- Critical Documentation: Customisation of Informed Consent Forms (ICF) and patient materials with country-specific details is essential. Certificates of Analysis for study products must align with the actual shipments.
- Language Requirements: All essential documentation must be supplied in English. However, patient-related documents, labels, and protocol outlines will need translation into Serbian.
- Insurance for Patients: Local insurance coverage is obligatory, with the insurer and sponsor signing the agreement.
- Helpful Pointers Ensure comprehensive listing of all institutions, principal investigators (PIs), and addresses in the insurance documentation to meet stringent requirements.
Oximio Clinical Supply Chain Solutions in Serbia
Oximio’s Serbian facility was established in 2020. Located in Belgrade, it serves as a pivotal access point for clinical trials across the Balkans, Asia, and Western Europe. Equipped with a cutting-edge customs bonded warehouse covering 353 m2, our facility ensures seamless storage solutions. Holding both a WHL License and ISO 9001:2015 certification, we provide sponsors with a diverse range of temperature-controlled logistics options tailored for pharmaceutical and biological products.
Our pharmaceutical license enables us to provide additional labelling services, enhancing efficiency. Backed by highly experienced and qualified project managers, we adopt a flexible approach, customising solutions to suit the unique requirements of each trial.
Discover our clinical trial logistics solutions in Serbia or contact us for further information. We’d be delighted to work with you.