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International Clinical Trials

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Oksana Maksimova of Clinical Trials Logistics explores the fast-developing clinical trials industry in eastern Europe and explains the benefi ts of operating in Ukraine

As the number of Phase 3 clinical trials conducted in eastern Europe has grown, Ukraine is one country that is benefitting from trials in rapidly developing areas of medicine such as oncology, pulmonology, cardiology, endocrinology and neurology. The potential in this field is not yet exhausted and the eastern European market is expected to continue to grow in the coming years, especially its related demand for cold chain and controlled drugs protocols handling. The local clinical logistics suppliers’ market in eastern European countries developed in line with the area’s clinical trials. Both sectors are moving towards permanent development, the improvement of quality and the extension of operation types.

There are a number of reasons why western pharmaceutical companies consider Ukraine an attractive location for their clinical trials:

  • The availability of numerous highly qualified research centres, as well as a considerable amount of professional pharmaceutical companies, such as CROs and logistics companies, plus pharmaceutical depots for clinical trials located in central and southern Ukraine (including Kiev, Kharkov and Zaporizhia)
  • The convenient geographic location of the country, which allows for fast delivery of medicine and clinical trials materials from the sponsor to research centres; delivery time within Ukraine does not take more than 24 hours to any part of the country because of a developed road network and a strong web of courier services, including global companies such as TNT, DHL and Marken
  • A full range of logistics services, which are provided by local clinical depots, including customs clearance procedures and IP handling
  • Up-to-date national legislation – from 16th February 2009 international standards such as GCP, GDP and GMP were implemented as national standards within the country
  • A well-developed labour market with professional staff, many of whom speak English fluently
  • A unique combination of professional staff, welldeveloped logistics, a high level of service and low costs compared with western Europe, which makes Ukraine an extremely competitive location for international clinical trials

This article will discuss the main aspects of logistics services available in Ukraine and the structure of these companies. It will also focus on clinical logistics more specifically, and explain the types of local depot, the range of services which they provide, the staff, the premises and the equipment, highlighting the benefits of working with these companies.

LOCAL DEPOTS

There are three main types of local clinical depots in Ukraine; independent clinical logistics depots (licensed and non-licensed); clinical logistics departments in CROs, and wholesale distributors of medicine. Local clinical trial depots in Ukraine are organised in accordance with international standards (GMP/GDP), and have high quality management systems and IT services in the warehouse.

SERVICES

All local clinical depots provide their clients with a full range of services in clinical logistics such as:

  • Import/export of submitting documents to the local regulatory authorities, license acquisition, handling of customs clearance procedure
  • Licensed and restricted storage of the investigational products in the correct temperature conditions (including ambient, refrigerated and frozen storage areas). Specially controlled medicine storage (virally based and narcotics) is also available, as well as additional labelling of investigational products in accordance with national legislation. Services of this kind also include local packaging of investigational products delivered to Ukraine in bulk, cold-chain services and internal database maintenance
  • Handling of bio-samples, including site collection, local depot storage and export to sponsor
  • Local purchase of registered medicines
  • Return of investigational products/clinical supplies from trial sites to local depots, as well as storage and destruction where necessary
  • Recall of investigational products/clinical supplies
  • Project documentation

 

Depot Capabilities

In accordance with international requirements, local depots are equipped with devices to take regular temperature/ humidity measurements in order to ensure that they maintain the appropriate storage conditions for investigational products. Equipment in all depots is certified and calibrated on an annual basis. Regular servicing of equipment is also performed by certifi ed internal companies.

Premises

All local depot premises are organised in accordance with dimensions and volumes of the stored supplies, as required by local regulatory authorities. Access to the premises is security-controlled and is equipped with fi re extinguishing systems and flood detectors. All zones are strictly divided up. Quarantine areas are marked out as separate. Twenty-four-hour temperature/humidity control systems are often implemented to provide controlled storage conditions and sanitary control is performed on a daily basis.

Local Depot Staff

Staff are well-qualified in all fields of the logistics chain, and in accordance with internal regulatory authority requirements staff also regularly attend external and internal training sessions.

Certification

Some local logistics companies are certifi ed in several sectors of the clinical logistics industry, according to the legislation of the country, such as the Wholesale Trade in Pharmaceutical Products Certificate, which covers storage, bookkeeping, distribution and destruction of narcotics and strong medicine certificate.

LICENSED CLINICAL DEPOTS

Licensed clinical depots provide significant advantages, which result in cost and time savings. Although not legally required to hold a license to store clinical trials products, a number of Ukrainian companies which aim to provide a high quality service obtain the license in order to extend their range of services.

There are a number of different licenses which allow the depots to offer a variety of services:

  • The Wholesale Trade License gives the opportunity to directly purchase, store and distribute registered medicine, which can be used as concomitant therapy while holding a clinical trial in the country
  • State permission for a customs-licensed warehouse considerably speeds up the process of incoming shipments customs clearance, and gives an opportunity to provide the correct conditions for storing the incoming products in the customs quarantine zone during the local customs clearance procedure
  • The Import and Turnover License (delivery, storage, distribution and destruction) for psychotropic matter, drugs and precursors provides legal opportunities to enter the shipment into the country and hold trials in the fi elds of psychiatry and oncology

The average term of license validity is five years; nevertheless, state authorities annually appoint representatives of regulatory bodies to review the license conditions.

Besides holding national licenses, many clinical logistics companies in Ukraine maintain international quality standards, such as GMP/GDP/ ISO. High quality management is implemented and in close partnership with international consulting companies. Widely experienced in the field of clinical logistics in the eastern European market, a lot of Ukrainian companies have been frequently examined by international auditors, which has raised their rating as experienced and qualified partners.

CONCLUSION

Eastern European logistics services can save both time and money, and can contribute to successful clinical trials campaigns. Local logistics companies aim to provide a service which is tailored to the demands of the customers in accordance to the legislation of Ukraine as well as international standards in order to render themselves a credible alternative to their western European counterparts. The growing clinical logistics industry in Ukraine can offer customers a high quality service equal to that of a western European logistics services provider. Thus, choosing the right partner for clinical trials logistics is the key to opening up a whole new world of opportunities in eastern Europe.


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Oksana Maksimova is Investigational Products Manager for Clinical Trials Logistics. In this role she organises the company’s local depot in accordance with international quality standards such as GMP/GDP. Oksana graduated from Moscow Medical University in Pharmacy. She has 10 years of experience in conducting clinical research and working with CROs and logistics companies in eastern European countries (Russian Federation, Ukraine and Belarus) in roles including Investigational Product Manager, Clinical Supplies Manager and Quality Assurance Manager. Email: oksana.maksimova@ct-logistics.net
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