Histopathology procedures supporting clinical trials have not received the attention they deserve in the industry. The trials are globalizing, and more biomarkers are being included in most clinical trials. And yet fewer CROs are given the attention to modern and reproducible quantitative pathology methods.
At Flagship, we work with clinical trials groups from early stage tissue biomarker development through later stage partnerships with larger CROs or reagent providers. Our pathologists can work with you to develop image analysis techniques and SOPs for your particular combination of biomarkers. Because we have experienced the challenges ourselves of placing pathology work and the logistics issues of global studies, we can help you utilize new technology to overcome some of these barriers. Flagship is fully 21 CFR 11 compliant for quantitative pathology support in clinical trials.
We have MD pathology partnerships with over two dozen board-certified MD pathologists, which allows Flagship to collaborate in providing quantitative image analysis techniques in specialized therapeutic areas.
We have a partnership in place with Vitro Molecular, a widely recognized leader in the deliver of high-quality immunohistochemistry in a CLIA environment. This allows Flagship to manage all aspects of a study as a regulated process, from the tissue preparation and IHC, through digital image analysis, to pathologist review and sign-out.
We have a collaboration with TGen’s Drug Development in novel quantitative pathology approaches to oncology clinical trials. Dr. Daniel Von Hoff’s team at TGen is one of the most exciting and innovative groups in the industry for individualized approaches to clinical trials.
Flagship has a local partnership with Dr. Angela Wyatt, a Northern Arizona dermatology and dermatopathology practice, that brings a CLIA lab and years of expertise in dermatopathology.