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SEND Explorer

Visualization and analysis of nonclinical study data in SEND format for identifying trends and outliers.

Solution by Certara
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Overview

SEND Explorer® is a validated, web-based nonclinical data software developed by Certara, designed to provide advanced viewing, data summarization, and visualization capabilities for nonclinical study data. Supporting SEND 3.0, 3.1, and 3.1.1 formats as well as various non-SEND data formats, SEND Explorer empowers nonclinical scientists to interact with study data, visualize treatment and time-related patterns, and communicate findings effectively across their organizations.

By leveraging SEND datasets prepared for regulatory submissions, SEND Explorer enhances internal decision-making processes and enables organizations to maximize their investment in SEND data. The platform is suited for nonclinical scientists, toxicologists, and regulatory professionals at biotech, large pharma, and CRO organizations who need to identify dose-response and time course patterns with confidence.

Core Visualization and Analysis Capabilities (All Versions)

  • Summary view for numeric data to visualize patterns and trends with summary statistics, scatterplots, out-of-concurrent-control range indicators, and percentage control mean calculations
  • Summary view thumbnail plots to display the distribution of subject data across groups
  • Line graphs to visualize patterns of group means and individual subject data over time
  • Clinical observations timecourse to reveal dose-related patterns and trends in clinical observations over the course of a study
  • Severity heatmap to visualize patterns and trends in both the incidence and severity of pathology findings
  • Cross-domain subject view to put a subject's data into perspective compared to its own group and control group, on a single day or over time
  • Single-study survival plot to plot survival in long-term studies

Advanced Multi-Study Features (SEND Explorer Plus and SEND Explorer Warehouse)

  • Correlations matrix to reveal pairwise correlations of endpoints for selected subjects, identifying those with histopathology findings in tissues of interest
  • Multi-study scatterplot timecourse to compare and contrast dose-response and timecourse relationships in a selected endpoint across a group of related studies, with the ability to overlay historical control reference range values
  • Multi-study histopathology barchart to visualize the prevalence and severity of histopathology findings across studies or in untreated control subjects
  • Historical control distribution to reveal the distribution of numeric data in control subjects across studies, stratified by selected fields of interest
  • Multi-study line graph to compare study-specific timecourse patterns in group means and individual subject data for one or more selected endpoints across studies

Enterprise-Grade Capabilities (SEND Explorer Warehouse Only)

  • Non-SEND data support and direct connectivity to data collection systems, accommodating a variety of source data formats
  • Custom domains and term reconciliation functionality to handle non-standard study data structures
  • Record override and metadata customization, enabling users to override records and create and populate ad hoc study metadata fields for querying data and filtering visualizations

Product Family Overview

  • SEND Explorer is available in three version levels: SEND Explorer, SEND Explorer Plus, and SEND Explorer Warehouse
  • Each tier builds upon the previous, with the Warehouse edition offering the most comprehensive data integration and customization capabilities
  • The platform provides an intuitive "easy-button" approach for generating single-study plots to reveal dose-response and timecourse patterns quickly

SEND Explorer integrates with Certara's broader preclinical and regulatory ecosystem, including Pinnacle 21® for CDISC SEND dataset creation and validation, and is complemented by Certara's toxicology consulting and SEND dataset creation services. The platform is backed by Certara's ISO 27001 certification for information security management, ensuring that nonclinical study data remains protected throughout the analysis and submission workflow.

Meta

Domain
Clinical & Regulatory Data Standards
Subdomain
Clinical Data Analytics & Visualisation
Software type(s)
Analytical Platform
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
Preclinical / Pre-Market
Target user(s)
Research ScientistBioinformatician / Computational ScientistQA / Regulatory Affairs
Compliance standard(s)
GxPISO 27001