Theorem Clinical Research has formed a strategic alliance with Charles River Laboratories (CRL), offering “an integrated solution from non-clinical testing and analysis through clinical development and registration”.
Together Theorem, a US-based provider of clinical research and development services, and drug discovery/preclinical research specialist CRL will provide non-clinical testing programmes in the fields of bioanalysis, immunogenicity and immunology to support clinical trials.
As Dr Marc Hoffman, Theorem’s senior vice president and general manager of biopharmaceutical development, pointed out, CRL develops and validates assays for non-clinical programmes.
Many of these assays “can be validated for human matrix and used for analysing clinical samples”, he said.
Bioanalysis portfolio
Charles River can call on a comprehensive bioanalysis portfolio for both non-Good Laboratory Practice and GLP programmes, the partners noted.
The CRL laboratories are equipped with the latest instrumentation to measure drug and metabolite concentrations in biological matrices, while providing full support for capillary micro-sampling and dried-blood spot analysis.
“The variety of advanced equipment ensures the capacity to meet critical deadlines,” the two companies added.
Alan Bartlett, executive director of laboratory services for Charles River Laboratories, welcomed the alliance with a “world-class clinical trials organisation”.
The partnership will enable “a seamless transition from preclinical testing into the clinical arena”, Bartlett commented.
