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Pact covers nonclinical through registration
September 12, 2013
By: Gil Roth
Theorem Clinical Research and Charles River Laboratories have formed a strategic alliance to provides nonclinical testing programs in the areas of bioanalysis, immunogenicity and immunology to support clinical trials. The pact will offer clients “an integrated solution from nonclinical testing and analysis through clinical development and registration,” according to a Theorem statement. “Charles River develops and validates assays in support of nonclinical programs, and many of these assays can be validated for human matrix and used for analyzing clinical samples,” said Dr. Marc Hoffman, Theorem’s senior vice president and general manager of biopharmaceutical development. Charles River’s research models, preclinical testing capabilities and clinical support services are backed by a comprehensive bioanalysis portfolio for non-GLP and GLP programs. Its laboratories are equipped to measure drug and metabolite concentrations in biological matrices and to provide full support for capillary micro sampling and dried blood spot analysis. The variety of advanced equipment ensures the capacity to meet critical deadlines. “We are pleased to partner with a world-class clinical trials organization like Theorem Clinical Research. Sponsors will benefit from the experience of both organizations. The alliance will offer a seamless transition from preclinical testing into the clinical arena,” said Alan Bartlett, executive director of laboratory services, Charles River Laboratories.
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