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VII. Performance Measures for Zeneca's Clinical Pathology Laboratory |
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One of the key advantages of centralized testing is to eliminate the discrepancies that can arise when assays are performed in different laboratories. At Zeneca every aspect of clinical pathology testing is standardized such that |
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(1) The same sample collection tubes are used by every center for all clinical trials. |
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(2) Every new instrument is checked for correlation against the old instrument. If a significant difference exists between the instruments, the old instrument will be retained to support the existing trials but samples from any new trials will be analyzed on the new instrument. |
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(3) Change of methodology and reporting units are only acceptable in extreme situations, or when a new instrument is commissioned, and with the consent of the senior trial physician and biometrician. |
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(4) Normal patient clinical pathology values are viewed annually but changes to the laboratory reference ranges are only considered on a 5-year cycle in consultation with senior clinical personnel. |
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(5) The laboratory boasts of a stable workforce of highly qualified staff most of whom have worked in the laboratory for over 15 years and all have a minimum of 5 years experience. |
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(6) Strict internal, quality control surveillance is maintained under the direction of a dedicated quality control officer. Multiple control samples from external quality control schemes, which also provide peer-group comparisons, ensure that accuracy and precision are maintained throughout longterm clinical trial programs. During 1995 the laboratory was ranked in the top 2% of 986 laboratories participating in a U.K. QC scheme for clinical chemistry. |
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These quality assurance procedures ensure the consistency of the laboratory data thus allowing longitudinal comparison between different clinical phases of the same drug or transverse comparisons for similar phases of different drugs. It is believed that the quality, data consistency, and sound data management offers a significant benefit to Zeneca's drug development process. |
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Other key performance measures, directed more towards satisfying the needs of our investigators, are (a) sample transport time, (b) promptness of reporting, (c) completeness of the reporting, and (d) competitive charges. |
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There are few courier companies that can offer a truly pan-European service. The majority of couriers are nationally based with reciprocal agreements for |
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