Preclinical Services

Gene Logic provides a broad and integrated portfolio of state-of-the-art contract study services to pharmaceutical and biotechnology companies, as well as government agencies. Our CRO services extend from proof-of-concept through clinical development support.

Gene Logics Preclinical Services can be divided into two sections: Toxicology Services and Laboratory Services.

Toxicology Services

Our GLP-compliant toxicology facilities are fully equipped to perform the entire range of regulatory supporting studies in a wide range of species. All studies conducted by Gene Logic are in compliance with the requirements of major regulatory agencies, including ICH, FDA, EPA, OECD, MOHW, and AAALAC International. Given our expertise, we have consistently met or exceeded quality and requirements set forth in both the development of protocols and the conduct of studies for regulatory submission. Our Toxicology Services offering includes services in the following key areas:

• General Toxicology

  Gene Logics General Toxicology Services consist of the design, execution, and analysis of research and regulatory studies that assess the safety and risk profile of pharmaceuticals, biologicals, nutraceuticals, environmental contaminants, and other chemical compounds. Our experienced expert staff, in combination with facilities that are equipped with the most advanced technologies, provide our clients with the knowledge you need to make better drug development decisions and guide your lead compounds forward in the drug development process.

• Developmental and Reproductive Toxicology

  Developmental and Reproductive Toxicology (DART) studies are an important specialization of Gene Logics comprehensive Toxicology Services, and accordingly, have dedicated resources, teams, and facilities. Our technical staff evaluates all stages of reproduction and development, enabling us to gather the most appropriate and focused animal data for estimating the stages of greatest potential human reproductive risk.

• Safety Pharmacology

  Safety Pharmacology studies are designed to investigate the effects of test articles on vital functions in mammalian species. Gene Logic provides experience in primary evaluations, including cardiovascular, respiratory, and central nervous system assessments, as well as experience in supplemental evaluations of renal/urinary, gastrointestinal, and immune function.

• Pathology/Clinical Pathology

  Integral to a complete toxicological evaluation is the pathological evaluation of blood, serum, organs, and tissues. Gene Logics Pathology Services combines the in-house expertise of our histology laboratory and resident pathologists to bring you concise, reliable, and timely reports.

Laboratory Services

Gene Logics Bioanalytical Services provide a broad range of Analytical Chemistry and Immunoassay Development Services in support of preclinical and clinical studies.

• Analytical Chemistry

  Gene Logics Analytical Chemistry Laboratory is a GLP/CLIA laboratory fully equipped to conduct and support proof of concept, toxicology, pharmacokinetic, and clinical studies of virtually any size, complexity, and species.

• Immunoassay Development

  The Immunoassay Development group designs, develops, and validated novel custom analytical and immunological assay for test articles in support of preclinical toxicology, PK, and clinical studies.

For additional information about our Preclinical Services offering, please navigate through the Contract Study Services section of the main menu.