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European Pharmaceutical Contractor

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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Industry Events

4th Annual Patient Recruitment and Retention in Clinical Trials

13-15 October 2008, Amsterdam

Patient recruitment is now consuming thirty percent of clinical trial time - more time than any other clinical trial activity - and almost half of all trial delays result from patient recruitment problems. As the recruiting culture becomes more sophisticated and the forces affecting patient enrollment grow more numerous and complex, pharmaceutical companies are striving to discover new strategies to facilitate enrollment in clinical trials. With increasing industry pressure to develop, test and market greater numbers of new drugs faster, pharmaceutical companies need to perform clinical trials as quickly as possible. Inefficient patient recruitment processes is a formidable barrier to pharmaceutical companies' success in launching new products. Improving the patient recruitment process is imperative to avoid wasted investments and eliminate costly delays in bringing new drugs to market -- today and even more so in the not-so-distant future. Improved patient recruitment presents one of the largest opportunities for pharmaceutical companies to eliminate delays in clinical trials, thereby making it possible to reduce time to market.  With patent time limits and large overheads meaning that any delays in the development timeline can be disastrous, a good understanding of how to successfully recruit patients for trials is vital for any company looking to succeed.
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