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
Our services include:
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
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.
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
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)
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
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
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.
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
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
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
Department of patient centric services was established in Farmasoft by the end of 2019 as a separate unit. It provides such services as arranging a taxi for patients, direct-to-patient deliveries, meal organization, nurse support, fuel compensation etc.
The list of services is targeted towards meeting the obligations as a full-cycle logistics provider to Farmasoft’ clients which are the TOP Pharma companies, Global and Local CROs and they are centered on the main goal of clinical trials industry – patients. More than ever before, they strive to be more patient centric in the way how they develop their medicines of the future