19A-5 Zviozdnaya str.,
223028 Minsk region, vBelarus
Clinical Trials Project Management
Tel./Fax +375 17 543 00 17
Logistics that advances Clinical Trials
Being the first company for conducting clinical trials in Belarus, for 16 years already Interfarmax has been in the lead in logistics services. During this time we have acquired a reputation for being a professional and reliable partner and established a high-quality up-to-date specialized depot for clinical trials that meets the requirements of world standards.
Rendering our services on the territory of Belarus we are able to provide CROs and sponsors with whole cycle logistics in Clinical Trial services - regulatory support, warehousing, distribution and destruction services on timely basis.
Implementing best practices and acquired experience we perform services in compliance with GDP, ISO 9001 international standards and requirements, local legislation and Interfarmax internal SOPs.
Being experienced in the sphere and having knowledge in local legislative features we are dealing with changing environments and provide our clients with the following services:
- Documentation preparing and submission for all necessary approvals of MoH and EC;
- Safety information submission to Regulatory Authorities and LECs;
- Import/export licenses applications for IMP and equipment;
- Importation, Exportation and Customs Clearance procedures;
- Close cooperation with Customs and assistance in urgent customs clearance on demand.
Our own specialized warehouse for clinical trials of the highest quality is built on Minsk ring road. Such location makes it attractive and accessible for heavy-load vehicles, allows to process and distribute considerable part of incoming shipments to Belarus, allows to deliver goods quickly to any point of Minsk and provides fast access to most Belarus traffic arteries.
For our clients we propose 24/7 secured storage zone that is divided per its purposes and temperature conditions in several zones: receipt, quarantine, storage, relabeling, rejected materials, packaging and expedition. Back-up storages also available.
- IMP and other study materials receiving and double checking;
- Separate incoming and outgoing flows;
- Detached back-up storages;
- Isolated premises for state-controlled drugs;
- IMP and other study materials accountability and tracking (electronic stock& data management);
- Continuous Winlog.wave central temperature and humidity monitoring and recording via EBI IF-400A interface in all storage areas;
- Archiving for 5 years (more upon request) in locked and restricted area safe from fire, water, light, humidity, rodents, flying and crawling insects, break-in.
Local sourcing helps reduce expenses on customs clearance and importation. In these sphere we provide the following:
- Local Purchase of comparator drugs, supporting therapy and other materials (equipment, lab supplies, etc.);
- Labeling of commercial drugs for clinical trials upon request;
- Best competitive prices from suppliers.
At Interfarmax relabeling of IMP is performed according to a Sponsor’s instructions and internal SOPs by trained staff in the following cases:
- Shelf-life extensions;
- Labeling of commercial drugs for clinical trials upon request.
Distribution of IMP and CTM
- Distribution to any point of Belarus within 24 hours;
- Urgent deliveries available;
- Own transport fleet;
- Temperature controlled deliveries in insulated containers supported by temperature loggers;
- Temperature readings provided upon delivery;
- Scheduled and emergency deliveries made on prior agreements with investigators;
- IMP and clinical trial materials exportation.
IMP and CTM recall and return
Interfarmax performs recall procedures on the ground of CRO/Sponsor’s, Manufacturer’s and Supplier’s official information about design or production defect or because of government regulations.
- Recall is performed at earliest possible date;
- Shipments stop upon recall within 24 hours;
- Return of a recalled batch from all sites at earliest possible date;
- Recalled stock is stored separately till the decision on further action;
- Mock recall procedures on regular basis;
- Return of expired, damaged and (or) unused materials for redistribution, export or destruction .
In Belarus destructions are done by state companies. Regulated by the Law of the Republic of Belarus № 271-3 "Waste management" dd. of 20th of Luly 2007. For today incineration is a priority method of destruction.
Interfarmax prepares materials for destruction (packing, documents) and then transfer to a licensed destruction company. Materials are protected, can not be approached by unauthorized persons.
- UE “Ekores” works according to ISO 9001 and OHSAS 18001
Storage areas at destruction facilities are secured.
Destructions are performed under a sponsor’s order for destruction. A destruction certificate issued on completion.