If you’re a study director, monitor, toxicologist, or any other non-clinical researcher or scientist, you’re aware of the imminent changes in drug development. The FDA will soon mandate that all non-clinical study data be submitted in the SEND format, and CRO data submissions to sponsor companies will also need to comply with SEND. To prepare for these changes and ensure data transparency, PointCross Life Sciences offers a comprehensive solution: the Drug Safety Information Management Suite (DSIMS).
DSIMS promotes the development of safer drugs through analytics and easier data access by standardizing the SEND format, including extensions for non-clinical and clinical study data. It provides a unified data and metadata repository, offering search, discovery, and data analysis functions for safety signal detection. Additionally, DSIMS provides viewing, graphing, and reporting tools for all non-clinical safety data.
DSIMS is available as an enterprise or cloud-hosted solution. You can easily load your SEND-formatted data or other non-clinical GLP study data from source collection systems into DSIMS’ secure controlled repositories. From there, you can analyze, search for, and detect safety signals and biomarkers within a single study or across multiple studies, including historical data.
Using DSIMS, you can accelerate your project decisions and pinpoint drug safety issues for further evaluation. The same tools that the FDA applies to submissions on their NIMS platform are at your disposal. DSIMS interoperates with compound registries and other company databases, allowing you to identify relationships between subject responses and compound classes and pharmacological families.
DSIMS also enables you to build, reuse, and share biomarker panels, facilitating collective collaboration around search results. PointCross, in business since 1999, understands that change is inevitable, especially in drug development and human safety. They aim to ease your transition by providing better biomarker detection and analytics, data validation, regulatory reviews and submission support, and study data conversion.
To learn more about DSIMS and how it can streamline your drug development processes, contact PointCross Life Sciences today. Embrace the upcoming changes with confidence and ensure the safety and efficacy of your pharmaceutical endeavors.