service

Clinical Study logistics

Quick patient enrollment and high proficiency of investigators, made Ukraine an attractive place for conducting international Clinical Studies. Farmasoft helps sponsors and contract research organizations (CRO – companies) by providing logistical support of their Clinical Studies in Ukraine.

We provide import, storage and distribution of investigational drugs, supportive materials for Clinical Studies and equipment. We guarantee integrity of your product from the time of import by the delivery to investigational sites. Being sole GDP certified depot in Ukraine, our storage facilities, equipment and services keep up with international standards and local legislation.

Our main differentiation is – many years of experience, high quality standards and broad range of services for Clinical Studies conducting in Ukraine.

All services are executed in strict adherence with Ukrainian legislation and international standards: GMP/GDP/GCP, ISO 9001. Business processes of the company are controlled by an integrated Quality System.

High quality of our staff was confirmed by multiple audits of our sponsors and Contract Research Organizations. Our employees consistently undergo inner and external trainings for improvement of their expertise and skills. Decision making flexibility, confidentiality and safety of our clients’ information are our chief priorities.

0  + 
Сlinical Studies
0  + 
imports
0  + 
deliveries

Our services include:

Full range of logistics for Clinical Studies

Our Project Managers help to choose optimal logistics solutions, optimize logistics budget at the time of a Study planning. The company processes prioritize Client’s interests and comfort. All communications are maximally automated and harmonized.

Import of Investigational drugs, equipment and CTMs

Our qualified employees provide you with support for each import operation.  We validate and adjust invoices and accompanying documentation, guarantee shortest time for each supply. Acting as Importer of record, we ensure a quick customs clearance for import of any investigational drug, controlled substances, temporary import of equipment etc.

Regulatory and customs support

Our company is ready to provide a professional advice about import and export procedures for medical equipment and other medical products. We ensure quick and qualified customs clearance of any Clinical Study materials. Thankfully to our practice experience of all statutory and regulatory base nuances with respect to local legislation and certified brokers of the company who received special training. We support in obtaining of permissions for Clinical Trials conducting as well as import permissions for investigational/comparative drugs, laboratory kits, export of equipment in the framework of Clinical Studies.

Storage at the GDP licensed pharmaceutical warehouse

Our warehouses with total area of more than 2800 square meters are equipped with high quality cold rooms, freezing equipment, monitoring and security devices and keep up with Ukrainian legislation and international GDP requirements. Control and recording of temperature is performed with the help of special validated equipment.  Storage of investigational drugs and collateral materials in different temperature conditions (15 ~ 25⁰C, 2 ~ 8⁰C, -25~-15⁰C, -80⁰C, -196⁰C).

Distribution

We guarantee delivery by our own vehicles “hand-to-hand”. We use validated solutions of Cold Chain to ensure provision of the utmost accurate maintenance of temperature conditions and other delivery requirements. We strictly comply with the GDP/GMP rules and recommendations as well as our own standard working procedures.

Comparator sourcing

Our company offers purchase of comparative medicinal drugs, adjunctive therapy or auxiliary medicinal materials and equipment which are needed for Clinical Studies. Our company Procurement Department constantly monitors the market for products availability, ensures optimal prices, in-time deliveries and full compliance with Regulatory requirements.

Equipment rent

Farmasoft has a constant stock of medicinal equipment and it helps to significantly reduce expenses and timelines of equipment delivery to sites. Also, our company takes full responsibility of the equipment maintenance service, validation, calibration and etc.

Labelling and re-labelling

We offer packaging services, additional labelling of drugs and Clinical Study materials as well as their re-labelling in accordance with Customers requirements and local legislation, following GMP directives.

Export

While conducting Clinical Studies in Ukraine, there is a need, to export bio-samples to Central Laboratories. Farmasoft acts as an exporter-of-record for bio-samples and prepares needed documents for export execution, since investigational sites do not have customs accreditation. We provide the whole range of service from bio-samples pick-up from clinical sites, provision of packaging, dry ice and/or nitrogen liquid, carrying out direct air freight to the destination country and delivery “to the door” of the laboratory. This gives possibility to optimize expenses by consolidation of shipments with dry ice. We also collect bio-samples and provide export on weekends.

Return and Destruction

Farmasoft offers the whole range of services on management of returns and destructions of pharmaceutical drugs and auxiliary materials and follows all legislative procedures under thorough control of experts with the full strict accountability. Upon the process completing, our client receives Destruction certificate and detailed report.