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As a laboratory dedicated exclusively
to the support of clinical trials, we recognize the importance of
having standardized testing platforms. Consequently, we utilize
the same instrumentation and testing methodologies at all of our
owned facilities and will gladly make available the QC studies to
assure our clients of the quality and consistency of our results.
We also understand the importance
of maintaining the same test methodologies throughout the course
of a clinical trial or clinical development program, and we make
every effort to do so. In the rare circumstance that a supplier
discontinues a test kit or reagent, preventing the continued use
of a test method, our scientific and data management staff will
perform the studies necessary to validate the new method and supply
the correlation data necessary to normalize and integrate test result
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The Challenge: A pharmaceutical
company asked ICON Central Laboratories to support a study requiring
the assay of 25,000 cytokines. The usual ELISA method for assaying
cytokines would be extremely expensive. The typical solution of
batch testing would adversely impact result turnaround. The sponsor
asked ICON Central Laboratories if they could find an answer to
their problem.
The Solution: To provide
a better solution for this client, ICON Central Laboratories set
up and validated the Cytometric Bead Array (CBA) testing platform
on a worldwide basis. With this new method, testing could be performed
as specimens were received, resulting in greater efficiency and
improved turnaround times. In addition, the method offered better
specificity with little to no cross-reactivity.
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