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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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