Download Clinical Laboratory Services

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.