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Clinical Laboratory Services Charles River offers a broad range of laboratory services to support clinical trials. We partner with our sponsors to provide high-quality assay and testing support for the lifecycle of their drug development programs, and focus on assay and testing services that transition easily from nonclinical laboratory testing into the clinical phase. Our scientific staff have extensive experience in transferring and developing methods efficiently and expeditiously to meet the needs of our sponsors. In many cases, the scientific staff have participated in the program from the start of the nonclinical program and can work closely with the sponsor in a collaborative manner as part of the clinical study team. This approach results in robust and reliable methods for clinical sample analysis and, combined with data management and data transfer expertise, enables us to produce high-quality, on-time clinical data to support drug approval and help our sponsors effectively make sound go/no-go decisions. Areas of expertise include: • Bioanalysis • Biomarkers • Clinical Sample Kits • Pharmacokinetics • Molecular Biology qPCR Studies • Technology Platforms • Immunogenicity and Neutralizing Antibody Assays • Biologics Testing Services • Data Management • Quality Control and Stability Testing Bioanalysis Biomarkers Charles River develops, validates and applies quantitative bioanalytical methods for the determination of pharmaceutical compounds ranging from small molecules to biopharmaceuticals. Our laboratories are equipped with the latest instrumentation to measure drug and metabolite concentrations in biological matrices, using a wide range of techniques and technology platforms, which allows us to provide our sponsors with short lead times in order to meet critical deadlines. Biomarker assays and pharmacodynamic endpoints are important tools in the determination of drug efficacy and safety. Our global scientific staff consult with sponsors early in their drug development programs to evaluate the most appropriate biomarker/pharmacodynamic endpoints, with the aim of translating the data across the program from discovery to the clinic. With extensive experience providing services such as assay design, validation, and sample analysis, Charles River offers step-by-step support for your drug development program. Our focus on strategic assay qualification/validation enables us to provide high-quality and accurate measurement of biologically relevant biomarkers, driven by scientific rationale. Pharmacokinetics The Pharmacokinetics groups at Charles River work closely with other operational departments to provide pharmacokinetic data for animal and human radiolabeled studies, nonclinical studies, human clinical trials and veterinary clinical studies in a timely fashion. Our pharmacokinetic consultancy service provides advice and support for all aspects of clinical pharmacokinetics and is offered as part of a complete development program, as a full-service single-study package, or as a stand-alone service. Upon request, pharmacokinetic parameter estimation output and reports include a comprehensive text interpretation of the data. Immunogenicity and Neutralizing Antibody Assays Charles River develops, validates and performs immunogenicity methods for the detection and characterization of anti-drug antibody responses at all stages of development. Our scientific staff are trained on the latest techniques for the design and execution of anti-drug antibody method validations in collaboration with our statisticians. Our services also include the capability to develop and validate cell-based neutralizing antibody assays to further characterize anti-drug antibody responses. Molecular Biology qPCR Studies We perform a comprehensive array of genomics-based assays to support all phases of drug development, from discovery and preclinical studies through clinical trials, in either singleplex or multiplex formats. Our molecular biology facilities have custom-designed, dedicated laboratories with separate sample processing (nucleic acid extraction), reagent preparation and amplification/product detection areas to minimize the possibility of cross-contamination. We isolate and purify DNA and RNA from a variety of tissues, body fluids and cells in culture. Both quality and yield of extracted nucleic acid samples are assessed prior to use, and our extraction procedures are optimized to provide the highest quality real-time qPCR results. Clinical Laboratory Services Biologics Testing Services Technology Platforms Charles River provides tailored Good Manufacturing Practice (GMP) global testing and manufacturing services to help accelerate biologic development from concept to product release. From biosafety testing and impurity detection to structure/ function analysis of biosimilars, our team of scientists and project managers ensure that the most appropriate methods are used for a product. Charles River provides flexibility in assay platforms for sponsors, due to the variety of validated systems we offer. Our laboratories are supported by a validated Watson™ Laboratory Information Management System (LIMS) for efficient sample tracking, collation of data and reporting. A variety of state-of-the-art assay platforms are available for the measurement of clinically relevant pharmacodynamic endpoints, including Beckman Coulter (BC) and BD flow cytometers, Luminex® Bio-Plex® systems, the Meso Scale Discovery (MSD®) platform, Applied Biosystems® real-time PCR systems and various ELISpot systems. Many assays designed on these platforms can measure multiple biomarkers at once, effectively reducing the amount of sample needed. Integration of multiplex data from the Luminex Bio-Plex system with the Watson LIMS means the large amount of data generated can be easily collated and reported. In addition, our ELISpot systems provide a powerful in vitro tool that reduces the need for additional in vivo studies. Quality Control and Stability Testing We conduct the quality control and release of Investigational Medicinal Products, applying the level of GMP appropriate to the product’s development stage. Qualified Person release is available for European trials. Stability studies can be conducted on active ingredients and finished products to support dosing for the duration of the trial as well as for full submission packages. Clinical Sample Kits Charles River provides clinical sample kits in support of clinical programs. With our vast experience in sample management and kit assembly for Phase I through III worldwide clinical trials, our kits are specifically designed to facilitate collection, storage and shipment of clinical samples such as plasma, urine, serum and whole blood without issue. Our clinical sample kits and related services are specifically designed to optimize all stages of the sample shipment process. Clinical sample kits are customized to client-specific requirements and virtually all individual needs can be accommodated. Our clinical sample kits can be sent directly to the clinical site(s) or to the client’s facility in one or more shipment(s). Data Management Through the use of Watson LIMS and overall IT support, our data is securely transferred to the designated data management group. The data management and transfer processes have been greatly enhanced through our collaboration with clinical trial CROs. Our partnerships allow nonclinical testing programs performed by Charles River in the areas of bioanalysis, immunogenicity and immunology to transition to support clinical trials with ease. Additional data management support is provided by myclinicalSM, our global data portal for customizable solutions and secure trial tracking. Clinical Laboratory Services [email protected] www.criver.com © 2014, Charles River Laboratories International, Inc.