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European Pharmaceutical Contractor

Financing Within the SMO Industry

In the early 1990s a new phenomenon in the conduction of clinical trials began to emerge. Up until then physicians conducted clinical trials within their own practices. GPs and specialists recruited trial patients from their own databases. However, Good Clinical Practice (GCP) guidelines subsequently became more stringent and physicians involved in day-to-day health care became increasingly reluctant to concentrate on clinical trials.

The concept evolved of an organisation dedicated to conducting clinical trials with specialist physicians and nurses. The organisations were initially called trial management organisations and later became known as site management organisations (SMOs).

They were company-owned sites which had the best control over the specific trial circumstances. Because of this, an SMO had to cover a number of fixed costs such as physicians' and nurses' salaries. As SMOs have to at very least cover their costs in order to stay in business, I have tried to summarise the cost factors and income in this article. This summary is based on a practical evaluation.


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By Dr Henk Mulder of Osteosupport

Dr Henk Mulder achieved his PhD in Internal Medicine and Endocrinology. He wrote his thesis 'Calcitonine concentration in blood in several disease sates' in 1980 at the University of Amsterdam.

After two decades of working as an Internist/Endocrinologist for the university hospital in Leiden and at a local hospital in Rotterdam, he founded the first European site management organisation named Good Clinical Practice (GCP). He participated in over 100 clinical trials as a Principal Investigator.

In early 2001 he left GCP and in June 2001 he founded Osteosupport - a hybrid company with integrated medical, paramedical and clinical trial activities. Osteosupport has been successfully involved in conducting three studies in the areas of arthritis, hypertension and male hormone replacement therapy.

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Dr Henk Mulder
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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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“PACK DIFFERENT” with EMBALLAGE 2008

“Business, Innovation, Outlook” are the watchwords for the 38th World Packaging Exhibition which opens in Paris from 17 to 21 November 2008. Fifteen months before the key packaging event of the end of 2008, EMBALLAGE displays its differences to offer you a new edition that is even more representative, international and rich in new features.
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