Expanded visualizations and data standards support workflows for preclinical scientists and toxicologists
Radnor, PA – 12월 18, 2024 – Certara, Inc. 글로벌 바이오시뮬레이션 선두기업(Nasdaq: CERT), a global leader in model-informed drug development, announced the availability of version 12.0 of the SEND Explorer® Product Family, released in November. SEND Explorer provides scientists advanced viewing, data summarization, and visualization capabilities for nonclinical study data using the Standard for Exchange of Nonclinical Data (SEND) format. The Clinical Data Interchange Standards Consortium (CDISC) developed the SEND standard to report individual animal data collected in nonclinical toxicology studies.
SEND Explorer is a validated, web-based application, designed by scientists to explore, and visualize preclinical data collaboratively. Toxicologists and biologists rely on SEND Explorer’s purpose-built visualizations to more readily detect and quantify safety trends in animal studies. This early detection is crucial to optimizing dose before more hazardous and expensive human studies begin. Unmanageable toxicity is a key driver of the failures that plague 90% of trials that enter the clinic.
Using SEND Explorer, scientists can generate single- and multi-study visualizations from both on-going and completed studies to make data-driven decisions and quickly address questions from development teams and regulatory authorities. SEND Explorer v12.0 adds new visualizations, incorporates additional features to further leverage the value of preclinical study data, includes several enhancements requested by scientists, and provides functionality to support SENDIG-Genetox V1.0, the SEND implementation guide that covers the organization, structure, and format of standard nonclinical tabulation datasets from in vivo genetic toxicology studies.
Key SEND Explorer updates include the following:
- New visualization capabilities: Adds new Multi-Study Exposure Plot and several new endpoint types for correlation to exposure (e.g. body weight, cardiovascular, organ weight) in the Single-Study Exposure Plot.
- Technology upgrades: Now supports upload of study data in SEND Excel format and SENDIG-Genetox V1.0, which will be required for vivo genetic toxicology data for studies starting after 3월 15, 2025.
- Additional user controls: Supports horizontal reference line(s) to emphasize a specific value or threshold in the Clin Path vs Histo Severity and Exposure vs Histo Severity Plots.
Industry demand for the SEND Explorer solution increased in 2024 as preclinical scientists and toxicologists require data visualization solutions tailored to their needs. The SEND Explorer solution is now used globally by multiple regulatory agencies, large and small pharmaceutical and biotech organizations, agricultural companies, CROs, and consulting organizations. Preclinical scientists choose SEND Explorer for its data visualization capabilities and robust product roadmap that ensures compliance with current and future regulatory trends.
Learn more about SEND Explorer at www.certara.com/send-explorer-software or download our free white paper on FDA SEND Dataset Requirements for Nonclinical Studies.
Certara 소개
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 66 countries. Learn more at certara.com.
Certara Contact:
Sheila Rocchio
sheila.rocchio@certara.com
Media Contact:
Alyssa Horowitz
certara@pancomm.com