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home > epc > winter 2002 > centralised laboratory testing for clinical trials: the advantages of using a global specialist
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European Pharmaceutical Contractor

Centralised Laboratory Testing for Clinical Trials: The Advantages of Using a Global Specialist

The number of new and innovative drugs emerging from the pipelines of pharmaceutical companies is increasing. Many biotechnology companies are also entering the clinical development phase, therefore requiring analytical support. Both types of companies have one thing in common: they rely on high quality laboratory results in order to evaluate the efficacy of their drugs. Most drugs being evaluated require lab work to prove their concept. This is different from the past when laboratory data was mainly used for safety reasons. How will this affect the central lab business and what should sponsors expect from these service providers in the future?

Outsourcing Laboratory Testing in Clinical Research: The Advantages of Using an International Central Laboratory
Sponsors in pharmaceutical and biotech industries have to decide well in advance if they want to perform all laboratory work centrally in their upcoming clinical trials. In addition to simplifying the logistical infrastructure of study management, a central laboratory may be able to increase the statistical power of the laboratory results obtained when biometrically evaluated. Better data quality will lead to a more reliable evaluation of efficacy and safety of the test drugs used. In most cases the use of a central laboratory may, in addition, reduce the overall study cost (see Table 1).


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By Dr Hermann Schulz MD, President and Co-Founder of INTERLAB GmbH

Dr Hermann Schulz, MD, FFPM RCP UK, is Co-Founder and President of INTERLAB Central Laboratory Worldwide GmbH, Munich. Before setting up his own central laboratory in 1994, Dr Schulz has held senior R&D positions in the pharmaceutical industry (Merck&Co, ICI/ZENECA and SCHWARZ) for the last 12 years.

He is currently teaching pharmaceutical medicine at the University of Witten-Herdecke and is a Member of the Board of the German Society of Pharmaceutical Medicine.


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Dr Hermann Schulz
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