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International Clinical Trials

The Case for Digitisation

 

Imaging core labs that use digital imaging of pathology slides are opening windows for pharmaceutical and biopharmaceutical companies to the cellular levels of illness and disease states. Digital pathology allows quick and efficient processing of subjects for inclusion and efficacy determination in clinical trials. Digital imaging uses many specimen types and stains, such as tissue biopsies and bone marrows.

For hundreds of years, skilled pathologists, physicians and surgeons have peered into the cells of patient tissues to discover disease causes or diagnose illnesses. The tools for this work included the microscope and glass slides containing specimens. Over time, slide scanners and software tools were developed, but produced very large digital images. The process was slow and storage sizes for these images meant that they were not feasible to use in large-scale clinical trial work.

DIGITAL ADVANTAGES

Today’s scanners and software use digital compression that allows for better management of slide image size. Slide scanners quickly digitise pathology specimens that enable imaging core labs to use more efficient procedures and meet tighter timelines. These scanners produce imagery in file formats and sizes that are accessible over a computer network or the internet. Imaging core labs have taken digital slide scanning one step further by using digital pathology on a worldwide scale in clinical drug trials.

Prior to the use of slide digitisation, labs prepared several sets of glass slides from each subject’s tissue block and sent them to reviewers. These glass slides would contain a different layer of tissue from the block. The chance of reviewers interpreting their specimen differently increased due to the fact that each reviewed a different layer.


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Frank Dunn joined Biomedical Systems as a Medical Writer in 2006. Prior to joining the company, Frank served as a Public Affairs Specialist with the US Coast Guard and the Department of Homeland Security for 22 years. He has extensive experience in clinical trial document development and has developed tracking methods to manage multiple study processes. Frank currently oversees the document process for all imaging clinical trials at Biomedical Systems.
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