Toxicology Studies
Toxicology data analysis and reporting for preclinical safety assessment.
GLP
Compliant
SEND
Ready
FDA/EMA
Submission
Overview
Our toxicology data services support CROs and pharmaceutical sponsors with statistical analysis, data management, and regulatory reporting for nonclinical safety studies. We handle SEND dataset creation, dose-response modeling, and integrated summary reports, ensuring your safety data meets the highest regulatory standards.
Features & Capabilities
Statistical Analysis
Dose-response, trend tests, pairwise comparisons, and historical control analysis.
SEND Datasets
Standard for Exchange of Nonclinical Data—submission-ready datasets.
Pathology Data
Histopathology data management, peer review support, and severity scoring.
Integrated Reports
Nonclinical overview and tabulated summaries for CTD Module 2.6.
How It Works
Protocol Review
Align statistical methods with study design and regulatory expectations.
Analysis
Execute pre-specified analyses with QC and pathologist review.
Submission
Generate SEND datasets, tables, and integrated summary documents.
What Sets Us Apart
- SEND 3.1 expertise with Pinnacle 21 validation
- Direct experience with FDA pre-IND and IND submissions
- Integration with major CRO data systems
- Board-certified toxicologist review available
Ready to Get Started?
Tell us about your project and we'll respond within one business day.
