Charles River is committed to providing exactly what clients need with flexible solutions, accelerated timelines and people who care about making a difference. Our experienced team helps clients to anticipate challenges, avoid roadblocks and expedite preclinical drug development with a wide array of safety assessment services and expert guidance through this important stage. Using state-of-the-art technologies in a global network of facilities, our skilled scientists execute individual studies and custom testing programs that are designed with a client’s goals in mind. Our regulatory experts ensure that all testing meets worldwide standards for quality and compliance, smoothing the path to market.
- IND Programs
- Laboratory Sciences
- Safety Pharmacology
- Anatomic & Clinical Pathology
- Environmental Impact Assessment of Human Pharmaceuticals
- Drug Metabolism & Pharmacokinetics
We have several decades of IND research experience, a unique range of services, and best-in-class expertise to help clients successfully initiate and complete an IND-enabling program on time and within budget. Our continuous focus on scientific excellence and guidance allows us to offer cost-effective IND programs tailored to the specific needs of our clients.
Our team of board-certified toxicologists, veterinary pathologists, veterinary surgeons, regulatory specialists and support personnel has designed and performed safety programs for more than 40 years. These programs employ a broad range of animal models and numerous routes of administration, and assess acute through chronic toxicity and carcinogenicity.
Our industry-leading specialty and general toxicology services include:
- Cell and gene therapy research
- Developmental and reproductive toxicology
- General toxicology
- Genetic toxicology
- Infusion toxicology
- Inhalation toxicology
- In vitro toxicology
- Musculoskeletal research
- Neonatal and juvenile toxicology
- Ocular toxicology
- Ototoxicity testing
- Safety pharmacology
Over the years, we’ve made significant investments in highly trained scientific, technical and support staff, superior facilities and technologically advanced instrumentation. These combined give us the ability to rapidly produce reliable data for many types of analyses using networked, validated data management systems.
Our multidisciplinary laboratory science offerings include:
- Analytical chemistry
- Formulation development
- Molecular biology
- Pharmaceutical sciences
- Physicochemical characterization
Our safety pharmacology program helps clients further the development of their product by investigating the potential undesirable effects of a compound on physiological functions in relation to exposure in the therapeutic range and above. We provide a comprehensive, global, harmonized program to meet the ICH guideline’s core battery and supplementary safety tests that may be needed based on early observations or concerns.
Our safety pharmacology offerings include:
- ICH S7A core battery and supplementary tests
- CNS, cardiovascular and respiratory
- Renal and urinary
- Autonomic nervous system function
- Endocrine and immune effects
- ICH S7B
- QT prolongation
- APD assays
A comprehensive assessment of pathologic changes is critical in the evaluation of toxicology and research studies, as well as for animal colony maintenance. As a world-leading CRO, we provide the contract toxicologic, clinical and specialty pathology services that support both early stage research with vivarium management and late-stage safety assessment.
Our unparalleled pathology services include:
- Clinical pathology
- Medical device pathology
- Molecular pathology
- Musculoskeletal pathology
- Phenotyping pathology
- Reproductive pathology
- Toxicologic pathology
- Ultrastructural pathology
With extensive experience in the conduct of studies to assess the environmental impact of test articles, we offer a full portfolio of services to support the environmental risk assessment requirement of a client’s marketing authorization application. Our deep understanding of both European and North American legislation allows us to guide clients through the regulatory maze. Dedicated environmental testing facilities provide modern, flexible laboratories that can accommodate all possible test scenarios.
Our services include:
Routine and specialized in vitro and in vivo metabolism and pharmacokinetic services are available for complete characterization of the absorption, distribution, metabolism and excretion of test articles in rodent and nonrodent species.
These services include:
- Absorption and bioavailability
- Dermal absorption
- Excretion/Mass balance
- In vitro ADMET
- Metabolite profiling and identification
- Protein binding
- Statistical analysis
- Tissue distribution (tissue dissection or QWBA)