Beyond its mission of basic-science research funded by grants, the department also offers a range of options for industry-sponsored research and development activities. This innovative and creative approach provides a pilot clinical laboratory testing ground for equipment, scientific instrumentation, novel technologies, and other industrial innovations for a whole range of companies, from small businesses to large corporations, and through various stages, from experimental testing to product launch. For these clients, the department has a number of faculty and staff on stand-by in chemistry, microbiology, molecular pathology, or anatomic pathology to perform diagnostics and product testing in a CLIA-like environment.
In Vitro Diagnostics Development and Clinical Trials
Group offers integrated services for every stage of clinical research — from development to commercialization. A results-driven academic enterprise, this group provides professional clinical laboratory medicine expertise for the laboratory diagnosticsindustry. The group’s clinical footprint and centralized laboratories affords near limitless resources forthe evaluation of developing clinical laboratory technologies.
The In Vitro Diagnostics Development and Clinical Trials Group team evaluates new In Vitro Diagnostic (IVD) devices or assays by comparison to conventional laboratory testing and/or similar molecular or analytic tests. Available services include reproducibility/precision testing, access to banks of clinical samples/tissue/microorganisms for the evaluation of new technologies, assays, antimicrobials, and detection/identification systems. The research team is comprised of personnel that are certified medical technologists as well as certified clinical research coordinators by ACRP/SOCRA with many years’ experience in all phases and processes for conducting clinical research (GCPs, IRB submissions, contract negotiations).
The In Vitro Diagnostics Development and Clinical Trials Group is actively involved with numerous corporations/investigators in the development of new technologies (alpha, beta, pre-clinical& investigator-initiated studies), collaborating with industrial and academic organizations on any phase of the developmental research and clinical trial process, including expert review of biopsy.
