For more than 60 years Charles River has been helping our global partners accelerate drug discovery and development by providing them with tailored research models and preclinical, clinical, support services. Our offerings span the entire drug development process, from discovery through market approval, providing our clients a seamless partnership throughout.
From the global standardization of our research models, to the high standards we set for our professional team and our state-of-the-art facilities and technologies, we can customize our products and services to meet customers specific research needs. With facilities around the world, Charles River is the ideal partner for moving a compound from animal to man in a rational, cost-effective, and timely manner.
The drug research and development process is highly complex, lengthy, and expensive, yet essential for delivering safe and effective therapies to patients. Even though the process is reasonably well-defined, drug development programs for any two products are fundamentally different for each product, as the exact testing and submission requirements are shaped by many unique factors. To help our customers navigate this process, Charles River offers a wide range of products and services that span the entire drug discovery and development continuum and can be tailored to specific research conditions. Our portfolio covers five distinct phases of drug research and development:
Basic Research: Charles River produces a variety of research model strains, including disease-specific and preconditioned models, for basic research and beyond. With more than six decades of experience, we have developed unmatched expertise in veterinary medicine and science. Our diagnostic testing and genetic monitoring services allow our customers to have the confidence that they are working with the exact models they need for their program. Our portfolio has also expanded to encompass not only the breeding and welfare of research models, but all of the scientific services, consulting, and staffing needs required to support quality in vivo research programs. To learn more, visit our Basic Research page.
Discovery: Charles River provides discovery services that help customers screen, rank, and identify lead compounds that have the greatest potential for development in an efficient, accurate, and reliable manner. With extensive research model, pharmacology, and toxicology experience, Charles River serves as an extension of our customers internal resources to develop customized programs. To learn more, visit our Discovery page.
Safety and Efficacy: Charles River offers a full range of in vivo and in vitro safety and efficacy testing services that comply with global regulatory restrictions. Our scientific, program management, and regulatory expertise help our customers cost-effectively produce evidence of a compounds biological activity and safety before moving to the clinical phase. Our customers also have access to our high-quality research models and related services, process manufacturing support, and laboratory services, as well as scientific consultants and regulatory advisors who can help interpret preclinical data and assist in the design of initial-stage clinical protocols. To learn more, visit our Safety Assessment page.
Clinical: Charles River provides both early and late phase clinical support services. With our experience in both routine and procedurally intensive studies, we can conduct well-designed clinical safety programs and offer expert oversight to correlate and verify preclinical findings. Our clinicians can assist in determining a drugs pharmacologic action, metabolism, side effects, as well as its overall clinical safety through a wide range of clinical study types. As clinical trials begin, further in vitro and in vivo nonclinical studies performed within our global network of facilities provide additional information to support continuation of clinical trials. With approximately 300 beds around the world, we have the resources to conduct Phase I clinical trials, including complex first-in-human trials. As clinical trials move to Phase II, III, and IV, Charles River offers a wide range of support services, specialty toxicology programs, process manufacturing testing, and regulatory advisory personnel to bring new chemical compounds into the marketplace. To learn more, visit our Early-Phase Clinical page or our Late-Phase Clinical Trials Support page.
Process Manufacturing: Charles River provides consulting services for the optimization of the product manufacturing process, starting from the small amount synthesized at the laboratory bench to large-scale manufacturing. We help our customers establish the physiochemical properties of a compound, best production practices, and process controls needed to efficiently and cost-effectively bring a compound to market. To learn more, visit our Process Manufacturing Support page.
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Created 4 years ago by Anonymous