DISCOVERY AND EARLY DEVELOPMENT

Nonclinical research and development that achieves its goal

Board-certified toxicologists, pharmacologists, chemists, biochemists, microbiologists, nutritionists, and other scientists with extensive experience in nonclinical research and development make it possible to meet project timelines and goals.

Expertly designed studies, professional management

GLP-required acute, chronic, carcinogenicity, teratology, and reproductive toxicology studies, along with short- and long-term efficacy studies, are expertly designed, monitored, and managed by our staff to achieve critical milestones in a timely fashion.

Support for every phase of development

  • Strategic and drug development planning
  • Customized protocol design development and implementation
  • Study monitoring and management
  • Study site inspection and qualification
  • Study placement and budget oversight
  • Regulatory compliance
  • Quality assurance and audits
  • Data analysis and study report review
  • Data management and presentation services
  • Report and manuscript preparation
  • CCSA’s portfolio of nonclinical-derived products under government and private client contracts and collaborations includes:
    • Scientific and technical review, summary preparation, and extraction of sponsored nonclinical toxicology reports for inclusion in regulatory submissions.
    • Nonclinical efficacy and toxicology (including GLP) study design and implementation.
    • Support for our government clients in nonclinical scientific literature research and surveys, data extraction and tabular information summarization, and literature review preparation for INDs/CTAs/IBs/CDPs/NDAs.
    • Implementation of information resources, including database and expert system development and maintenance.
    • Implementation of collaborative and secure data sharing resources.
    • Scientific and technical review, summary preparation, and extraction of sponsored nonclinical toxicology reports for inclusion in regulatory submissions.
    • Technical and scientific support for projects including the publicly available PHS- 149 Survey of Compounds Which Have Been Tested for Carcinogenic Activity, and the National Dialogue on Cancer (now C-Change)’s Working Group on Surrogate Endpoints Database.
    • Understanding of compliance with the regulatory and government-required guidelines for nonclinical testing in support of R&D programs.