OCT offers the following clinical supply management services in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria:
- Obtaining of import/export licenses;
- Preparation of documents for customs clearance;
- Customs clearance of study medication;
- Delivering all clinical trial materials and medications to the research centers;
- Temperature tracking in cool-chain delivery;
- Shipment of biosamples to a central laboratory;
- Export of biosamples to a central laboratory ;
- Purchasing and distributing additional equipment, various concomitant materials and supplies;
- Allocation and transportation of the study medication;
- Tracking of the study medication during delivery;
- Providing the insurance of the cargos and carrier responsibility if necessary;
- Drug accountability at sites
- Selection of Central Depots in Russia, Ukraine and Belarus
Customs clearance of study medication
Requirements vary among CEE countries, particularly among non-EU countries such as Russia, Belarus and Ukraine regarding the import/export of study drugs and supplies. Sponsors may experience time-consuming delays in drug import to Russia, Ukraine and Belarus if they do not have a reliable partner in this region who could guide them throughout the process.
In our work related to delivery and customs clearance of medications, we employ services of the world leaders of this industry like DHL, World Courier and Alpha Courier, whose reputation and professionalism are confirmed by many years of experience both in countries of activities of OCT and worldwide.
The company works closely with professional and experienced customs brokers engaged in drug clearance with the customs authorities of the countries of activities of OCT.
We also provide management of supplies and internal transportation of bio-materials and required equipment for clinical trials in Eastern Europe.
Warehouse
Given that study materials need to be imported into Russia, Ukraine and Belarus well in advance of investigational site distribution, for big phase II and III clinical trials in Russia, Ukraine and Belarus, it is advisable to have warehouses in these countries.
OCT works with state-of-the art warehouses in Russia, Ukraine and Belarus. The warehouses were audited by OCT QA Manager.
Warehouse facilities provide:
- Restricted, computer-controlled access to the storage spaces;
- Quarantine chamber;
- Fully computerized temperature and humidity control;
- Warehouse facilities allow to store medications at different temperature modes, research protocol conditions and sponsor requirements;
- Multiple refrigerating modes from +8 to -10 , from -10 to -40 , from -40 to -86;
- All refrigerators and freezers are highly resistant to voltage drops, increasing ambient temperature and tough input/output modes;
- There are alarm systems with preset values responding to power outages and temperature fluctuations;
- Providing daily graphs;
- Various other options.
