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 a 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.

Regulatory approval process​

Submission to CEC and RA (MoH) can be performed in parallel and electronically (via a web portal called ADIS). After the CEC approval for research is obtained, the RA approval is issued 30 days later.​

Agreements with sites and investigators​

Agreement negotiation can be started before the study approval, but some sites require at least a CEC approval to engage. ​

LEC review and approval ​

CEC and RA (MoH) reviewing processes can be done in parallel. 

Trial sites’ location​

All sites are located within an approximately 350 km radius of Belgrade.​

Legal entity​

A local legal entity is required for submission.​

QP Declaration / GMP certificate​

GMP Certificate, Manufacturing Authorization, and QP release (depending on EU/non-EU manufacturing) are needed for submission, and the CoA for the actual batches to be imported into Serbia.​

Documents requiring special attention​

ICF and all patient materials should be customized with country-specific information.​ Certificates of Analysis for any product used in the study must match the actual shipments.

Official language ​

Essential documentation should be submitted in English. ​Patient-related documents, labels, and protocol synopsis must be translated into Serbian. ​

Patient insurance​

Local Insurance is required. The Insurer and the Sponsor sign the agreement. 

Useful tips

There is a strict requirement to list all Institutions and the PI names and addresses in the insurance documentation.​

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 Just-In-Time (JIT) 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. Guided by GMP best practices, our team navigates the intricate landscape of clinical trials logistics, prioritizing the well-being of your patients at every step.

Discover our clinical trial logistics solutions in Serbia or contact us for further information. We’d be delighted to work with you.