Choosing CROs

Much has been written about the pros and cons of working with big versus small Contract Resource Organisations (CROs).

One of the main reasons given by small pharmaceutical and biotechnology sponsors for supporting partnerships with smaller CROs, according to Wickham Laboratories, is the phenomenon of being abounced' by a big pharmaceutical sponsor.

Another reason beginning to be recognised is that of the benefits which come from the working relationship between sponsor and service provider that is easier to achieve with smaller CROs.

Sadly, there is a perception that problem solving abilities are lacking in bigger organisations, a gap that smaller contract resource organisations are able to fill.

This is most important to the virtual or semi-virtual organisation where sponsors seek to developing relationships with their suppliers which enable and encourage a proactive approach at all stages of a project.

Most laboratories providing bioanalytical services will have GLP accreditation, and although this does not apply to human clinical trials, sponsors usually insist upon it.

If an establishment does not conduct GLP studies they will have great difficulty in maintaining their accreditation.

May 1st 2004 saw the introduction of GCLP to the list of quality standards to which a laboratory can operate, bringing the analysis of clinical samples under the GxP umbrella.







Wickham Laboratories Limited is based in Wickham, Fareham, Hampshire, UK. www.wickhamlabs.co.uk

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