Biomarkers and complex clinical assays are recognized as essential tools for the development of therapeutics, allowing improved and better-informed clinical trial design through indicators of target engagement and those that enable patient stratification. Our Team can help design and validate new assays in our CAP/CLIA laboratory, undertake method transfers or migration modification of existing novel methods.
Our expert Board-certified pathologist and PhD scientific teams are on hand to provide protocol consulting, Biomarker selection / consultation, Biomarker assay development, Companion diagnostic selection / validation, access to pathology tissue and biobank resource, and support all aspects of your Phase I, II, III specialty laboratory testing.
Our Expertise in CAP/CLIA molecular diagnostics, pathology, informatics, innovative solutions, and technologies makes us an ideal choice to meet your IVD/CDx testing needs. We have over two decades of experience with major instrument and diagnostic reagent manufacturers in providing support for IVD/CDx studies. Our services include.
The key to a successful clinical trial is accurate, clean, quality data. Our team of data managers
provides you with data in customized formats exported to your data management teams from our in-house laboratory information system (LIS).