Preclinical CRO Services

Toxicology studies define the safety profile that supports first-in-human dosing. A typical IND package combines repeat-dose studies in a rodent and a non-rodent species, genetic toxicology and safety pharmacology, with reproductive and other specialized studies added as the program advances. Pivotal studies run under GLP; dose-range finding and exploratory work usually do not.

Pharmacology studies show that a compound does what it was designed to do: binding and functional assays in vitro, then efficacy, dose-response and target engagement in animal models of disease. Model choice matters more than almost anything else here, so look for CROs with validated models and historical data in your indication.

Disease models show whether a candidate changes the course of a disease, not just whether it reaches its target. Most are induced (chemically, by diet or surgically) or genetic, and each reproduces only part of the human condition, so the right model depends on which endpoint matters for your mechanism. Ask for the lab’s baseline and positive-control data before comparing on price.

ADME and pharmacokinetic studies describe how a drug is absorbed, distributed, metabolized and excreted. In vitro ADME screens guide chemistry, in vivo PK supports dose and species selection, and toxicokinetics links exposure to findings in the safety studies.

Bioanalysis produces the concentration data behind every PK, toxicokinetic and biomarker result. LC-MS/MS is standard for small molecules and ligand binding assays for large molecules, with methods validated to ICH M10 when the data support regulatory studies.

Surgical models and specialized delivery routes depend on the skill of the surgical team as much as on the facility: chronic catheters and vascular access ports, intrathecal and intracerebral delivery, intravitreal injection and telemetry implantation. Ask about procedure volume and complication rates in your species. Our team has hands-on experience with these procedures.

Safety pharmacology assesses effects on vital functions. ICH S7A defines a core battery covering the cardiovascular, respiratory and central nervous systems, and ICH S7B adds hERG and in vivo QT assessment. Conscious telemetry in a non-rodent species is the usual approach for cardiovascular endpoints.

Oncology models range from cell-line xenografts and syngeneic models in immunocompetent mice to patient-derived xenografts and humanized mice for immuno-oncology. The right model depends on mechanism: immune-dependent agents need an intact or humanized immune system.

CNS programs have to contend with the blood–brain barrier, so many rely on direct delivery into the cerebrospinal fluid or brain, alongside behavioral, neurodegeneration and pain models and CNS safety assessment.

Antibodies, gene therapies, oligonucleotides and cell therapies bring their own preclinical requirements: species selection based on pharmacological relevance (ICH S6(R1)), immunogenicity, biodistribution and often specialized routes of administration. Not every CRO has worked with each modality, so ask about programs similar to yours.

Antibody programs start well before the first animal is dosed. Discovery labs generate binders by immunizing animals (hybridoma or single B cell sorting) or by screening display libraries, then engineer the lead through humanization, affinity maturation and Fc changes that tune effector function. Characterization data such as binding kinetics, epitope and Fc function feed directly into species selection for the preclinical package, and anti-idiotype antibodies become the reagents for later PK and anti-drug antibody assays.

Supporting services that round out a preclinical program: pathology, formulation development, regulatory strategy and submission support, medical device testing, including ISO 10993 biocompatibility and implant studies, protein and cell line production, and veterinary drug development.