A full complement of board-certified toxicologists, pharmacologists, chemists, biochemists, microbiologists, nutritionists, and other scientists with extensive experience in nonclinical research and development make it possible to meet clients’ project time lines and goals.
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.
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We can assist with:
- 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
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Examples of CCSA’s portfolio of nonclinical-derived products under government and private client contracts and collaborations include:
- Nonclinical efficacy and toxicology (including GLP) study design and implementation.
- Support to our government clients in nonclinical scientific literature research and surveys, data extraction and tabular information summarization, literature review preparation for INDs/CTAs/IBs/CDPs/NDAs.
- Implementation of information resources, including database and expert system development and maintenance.
- 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 and compliance with the regulatory and government-required guidelines for nonclinical testing in support of R&D programs.
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