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Central and Eastern Europe: Quality and Quantity

Speed to market is more important than ever, with enormous pressures on the pharmaceutical industry to develop and produce novel therapies as quickly as possible. To avoid delays, pharma are increasingly using sites in Central and Eastern Europe to boost patient recruitment. Impressive recruitment rates can lead multinational pharmaceutical companies to view the quality of the data with caution. Our experience has shown that both quantity and quality are achievable.

When considering Central and Eastern Europe (CEE), with its array of cultures and languages, there must be no impression that this is one homogeneous region. Following radical political and economic changes, which have not only affected the pharmaceutical industry but health care management too, pharma have recognised the potential in CEE countries for conducting international clinical research.

Over the last two decades there has been a substantial increase in pharmaceutical sponsored clinical trials. This has resulted in the formation of clinical research organisations (CROs) who have developed expertise in CEE countries, working according to good clinical practice (GCP). Local monitors are usually highly motivated and well-educated medical professionals who are native to the country in which they work. Many monitors are medical doctors and are fully acquainted with local health care systems and national regulations. As medical professionals, they are fully conversant with local medical practices and can therefore easily liase with investigators at their professional level.


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By Nicky Dodsworth, Director of Quality Assurance at Pharm-Olam International (UK) Ltd

Nicky Dodsworth is Director of Quality Assurance at Pharm-Olam International (UK) Ltd, a CRO specialising in setting up, monitoring and project managing clinical studies in Central and Eastern Europe. She has been involved in clinical research and quality systems activities since the mid-1980s, in both pharmaceutical and contract research organisations (CROs).

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Nicky Dodsworth
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