Discovery & Early Development
We’re committed to expertly designed studies and meticulous management, offering expert support throughout every phase of nonclinical research and development to ensure your project achieves its goals with confidence and clarity.
Advancing Nonclinical Discovery & Development
Nonclinical Research and Development that Achieves Its Goal
Expertly Designed Studies, Professional Management
World-Class Support for Your Project
We recognize that exceptional support is the backbone of successful development, which is why we are dedicated to accompanying you through every phase of your project with expertise and care. From strategic planning to regulatory compliance, our team of seasoned professionals is committed to ensuring that each step is executed with precision and clarity. We provide tailored guidance and oversight, helping you navigate the complexities of nonclinical research and development while fostering an environment of trust and collaboration. With our unwavering support, you can focus on achieving your goals, confident that you have a partner who genuinely cares about your success.
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.
- 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.