SEND Data - Strategic Advantage
By partnering with us, you gain access to insights from the SEND Explorer platform, the same platform used by FDA reviewers to interrogate drug safety data based on the results from toxicology studies, allowing you to resolve findings that can lead to unexpected delays or clinical holds, saving months of development time.
De-risking Send Data
FDA requires submission of SEND data files with most toxicology
studies to thoroughly interrogate the safety of your drug. Sponsors
should insist on having this equivalent insight into their nonclinical data.
Biologics Consulting can perform this evaluation for Sponsors using the same powerful program (SEND Explorer) designed for and used by FDA reviewers.
This can make all the difference in de-risking your submission and
gaining timely approvals.
Key Advantages
- Interrogation of your data in SEND files using SEND Explorer prior to submission
- Provides the ability to identify important patterns/trends that FDA reviewers can readily visualize
- Improve your understanding of the factors contributing to toxicological findings
- Ability to visualize key toxicological findings in a format familiar to and easily confirmed by FDA
- Enhance and accelerate both regulatory submissions and responses to request for information (RFIs) from FDA
- Avoid unnecessary delays or clinical holds due to toxicological issues that were not apparent
- Ensure that you are clearly the expert on your product’s safety profile at the time of submission
See your data through the eyes of the FDA
- Standard Exchange of Nonclinical Data (SEND) files are required for nonclinical toxicology data to be submitted to the FDA and permit computer program-based analysis
- SEND Explorer (SE) is a tool used by FDA reviewers to visualize and analyze nonclinical safety data organized in a standardized format within SEND files
- SE provides powerful options for visualization of complex toxicology data, facilitating identification of patterns and outliers and enabling multi-study and multi-species comparisons for a broad view of product safety, potential safety concerns and interrogation down to the level of individual animals
- Powerful heat map visualizations of microscopic observations across all tissues, doses, sexes, and individual animals, permit rapid identification of tissues of interest, evidence of dose-dependance, and the extent of recovery
- Similarly, SE permits visualization and understanding of the relationships between clinical pathology, severity of tissue histopathology, dose and sex
- The level of visualization, interrogation and summarization of SEND data possible with SE is not available to most sponsors. Partnering with us can provide this important advantage.