Gain Nonclinical Drug Safety Insights with Real-Time Data Analysis

To understand the value of reviewing non-clinical study data in real-time, let’s review the typical lifecycle of nonclinical studies and the types of data collected during each phase:

1. Pretest Phase – Data collected before dosing starts such as body weights, clinical observations, and lab results to establish a baseline.
2. Dosing Phase – In-life data for body weight, clinical observations, food consumption, and drug exposure are collected.
3. Recovery Phase – Measurements done in the pretest and/or dosing phase continue for animals in the recovery groups.
4. Post-life Phase – Gross pathology, organ weights, and histopathology findings are gathered at the study’s conclusion.

See the figure below that shows the flow and availability of data across all phases of a preclinical study.

Historically, interim study data has been shared in formats like PDFs and Excel files, which come with significant drawbacks:

• Lack of Visualization – PDFs offer static tables with limited insights or context for interpreting relationships between data points.
• Efficiency Challenges – Raw Excel files may vary in format and structure, often requiring significant manual effort to generate meaningful insights.
• Delayed Integration – Delays in the delivery of interim results and variable legacy data formats hinder the integration of data with results from other studies conducted for a drug program, delaying decision-making.

What if you could access and analyze nonclinical study data in real-time? That’s exactly what SEND Explorer enables. Here’s how:

• Streamlined Data Exchange – Dynamic and scheduled data exchanges in standardized formats (e.g. SEND) between Contract Research Organizations (CROs) and sponsors improve collaboration.
• Visualization Capabilities – Certara’s SEND Explorer software enables researchers to generate compelling graphs and charts to identify patterns, such as dose-response relationships or species differences.
• Cross-Study Analysis – Interim SEND datasets integrate seamlessly with completed studies, building a holistic nonclinical safety profile for the program.
• Enhanced Safety Assessments – Toxicologists can detect trends, refine study designs, and assess safety margins earlier than traditional methods allow.

SEND Explorer allows nonclinical scientists to perform seamless safety analysis and expedite the assessment of compound safety.

Certara’s SEND Explorer is revolutionizing how researchers use SEND data. This platform enables:

• Automated workflows for analyzing interim and finalized study data.
• Seamless data integration from various sources, including CROs, specialty labs, internal studies, and completed/historical studies.
• On-the-fly visualizations like graphs and charts, which facilitate the interpretation and communication of key findings.
• Data analysis and visualization with the same tool used by regulators to minimize unexpected submission queries and delays.

Real-time data analysis is the future of nonclinical safety assessment. The SEND standard provides a clear path toward integrating and interpreting complex animal study data through automated data feeds and standardized data formats. Using Certara’s SEND Explorer, toxicologists can optimize data analysis and visualization activities while delivering more efficient and timely safety assessments.