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European Pharmaceutical Contractor

Perspectives in Preclinical Development

Bridging the Gap Between the Pharmaceutical and Preclinical CRO Industries

Pharmaceutical companies have traditionally outsourced a proportion of their preclinical development studies to contract research laboratories. This co-operation can be traced back to the mid-sixties and the proliferation of regulatory guidelines which followed the thalidomide disaster earlier that decade. At that time, the international requirements for protocol-driven toxicity studies for new pharmaceuticals put a strain on the resources of many drug companies.

The answer for many was to outsource individual studies to the rapidly-evolving contract research industry, pioneered by companies such as Huntingdon Research Centre in England and Inveresk Research in Scotland. These organisations turned their focus from experimental nutrition studies to the toxicity testing of drugs and other chemicals.

As the science of toxicology developed, so did the demands of the regulatory authorities, often resulting in inconsistencies between the various agencies. The introduction of Good Laboratory Practice (GLP) in 1978/9 also made it more difficult for some drug companies to perform studies themselves, adding further momentum to the growth of the CRO industry.


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By Thomas Allen, Director of Allen Preclinical Consultants GmbH

Thomas Allen is a Director of Allen Preclinical Consultants GmbH, based in Switzerland. His career has spanned more than 25 years with European CROs and pharmaceutical companies, most recently with RCC Ltd where he was a member of the Executive Committee and, for many years, Director of Toxicology.

Thomas has a degree in Zoology and Physiology from the University of Sheffield and is a Diplomat of the Royal College of Pathologists and a European Registered Toxicologist.

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Thomas Allen
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