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Clinical trials logistics
Recently Ukraine has become one of the key areas of clinical studies
sponsored by international pharmaceutical companies. In practice, however,
law peculiarities (customs clearance, certification etc.) call for logistics
services provided by a specialized company.
Farmasoft Ltd. is one of the few Ukrainian companies that specialize in the
field of clinical trials logistics. Our aim is to provide all-in-one
world-class services and accommodate all customer's requirement while
adhering to the local law.
Our services include:
- Study kick-off (learning the sponsor's needs&requirements, preparation
of working instructions).
- Obtaining import/export licenses, certification.
- Customs clearance of study medications, equipment and expendables.
- Receipt, accounting for and storage of medications according to
customer's requirements and world standards (we can store at -70 to +25
°C).
- Relabeling of the study medication as needed.
- Preparation and dispatch of the study sites shipments (with cool chain
maintenance if required).
- Return, accounting for and storage of the study medications pending
return to sponsor or in-country destruction (Ukrainian destruction
facilities are available).
- Support of concomitant therapy (purchase of the medications in
Ukraine).
All services are performed in strict adherence to local laws and GMP/GCP.
Work processes are governed by a single system of SOPs.
Our experience includes more then 40 clinical trials projects. High
qualifications of our staff have been confirmed by numerous audits by the
sponsors. Staff regularly undergoes internal and external training to
maintain high standards of education and skills.
Confidentiality and safety of sponsor's sensitive information is our top
priority.
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