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partnership with a contract packer, who provided and distributed trial specific phlebotomy packs while, for sample transport, a world renowned courier company was contracted to achieve the effective pan-European transportation of samples to the laboratory. |
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Improving patient data management was achieved by the installation of a new computerised Laboratory Information System whose extensive and easily accessible electronic database allowed efficient demographic management. Extensive use of barcodes on documents and samples aided sample tracking while the automated report printing and electronic faxing of results supported the same day reporting of results. Customized reports provide monthly updates on the number of patients screened and enrolled into a study and history prints provide details of recorded patient demography information. All clinical trial data is automatically transmitted over night to the Medical Function and recent enhancements have allowed trial data to be electronically transferred to CROs involved in Trial Center Management or Trial Data Statistical Analysis. |
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Laboratory personnel actively participate in pretrial protocol review meetings; training sessions for the CRAs involved in center monitoring and pretrial investigator meetings where the investigator can directly resolve any clinical pathology issue. Although the laboratory is fully GLP certified, in order to further reassure our investigators, clinical pathology accreditation was sought and awarded, without reservation, in 1992. |
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The support of these administrative activities has necessitated an expansion in staff numbers and a realignment of administrative activities with two staff |
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Fig. 5
The number of laboratory staff employed for either administration (dark bars) or
sample analyses (gray bars) are shown for the period 1990 to 1996. The increase in
productivity (i.e., number of samples analyzed per individual) is also displayed. |
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