For our government and private clients, we provide drug development, toxicology, and literature research support services and have broad experience in critical evaluation of laboratory and nonclinical/clinical data, structure-activity relationships, information technology, and strategic planning for drug development.
CCSA reviewed and abstracted chemical carcinogenesis literature including National Toxicology Program (NTP) Technical Reports during a 12-year period under contract (contract N02-CB-97020) with NIH, and the information thus collected and organized was published as PHS-149 Survey of Compounds Which Have Been Tested for Carcinogenic Activity. PHS-149 continues to be the only comprehensive source summarizing all experimental studies attempting to induce tumors in animals by the administration of exogenous chemicals. Widely used throughout the scientific community, it was an excellent source of ideas for structure-activity studies in chemical carcinogenesis and one of the standard reference works in biomedical libraries.
CCSA has been involved in providing critical evaluations of the carcinogenicity of individual chemicals and of groups of chemicals related by structure, use or environmental occurrence. These evaluations were used by the NCI-sponsored interagency Chemical Selection Working Group for making decisions to test compounds in the lifetime bioassays. With the formation of the NTP and oversight subgroups of the Clearinghouse on Environmental Cancer, these data summaries were used by a wider audience. As part of this effort, Dr. Caroline Sigman and CCSA developed the Chemical Carcinogenesis Research Information System (CCRIS)—a proprietary database of evaluated carcinogenicity testing data from the literature.
CCSA has reviewed, maintained and managed nonclinical laboratory results from in vitro mechanism studies and in vivo efficacy studies as well as formal toxicology studies performed under 21 CFR Part 58 in proprietary databases. Reports prepared from these databases provide up-to-date data for our clients such as NCI staff and scientists, for agent development activities (e.g., CDPs, summaries, worksheets and monographs), as well as preparation of content for regulatory submissions (e.g., IND annual reports).