CDISC SEND Submission Resource Center

Pristima Pre clinical Platform CDISC SEND compliant

Xybion provides a CDISC SEND compliant Submission solution as part of its preclinical software platform, Pristima. The FDA has issued the final guidance on standardized electronic data. Now, studies starting after Dec. 18, 2016, for applicable NDAs, BLAs and ANDAs, and studies starting after Dec. 18, 2017 supporting IND submissions, must be submitted in accord with electronic standards specified by FDA (SEND for nonclinical). Xybion is a registered solution provider for CDISC and can ensure your studies are CDISC SEND Compliant.

Learn More at FDA.gov

Pristima SEND Submission Management

Pristima Suite, provides a module to facilitate the FDA SEND standards for preclinical submissions. The Standard for Exchange of Non-Clinical Data (SEND) is an implementation of the Study Data Tabulation Model for non-clinical studies. This standard was developed by the Clinical Data Interchange Standards Consortium’s (CDISC) SEND.

Watch our Video on how Xybion Addresses SEND (CDISC-SEND Compliant)

Standard for Exchange of Non-clinical Data (SEND) is the content standards set by the FDA for the submission of pre-clinical safety assessment data. By creating a recognized standard for submission data, SEND facilitates communication between research organizations, sponsors and regulators.

The Pristima® Savante/SEND component is fully integrated with the full Pristima® Data Management Suite and is designed to comply with the FDA regulatory guidelines and standards. Acting as a channel to concentrate and reformat pre-clinical data, the Pristima® Savante™ / SEND component is designed to support CDISC SEND compliant data submissions to the FDA from a variety of data sources, including Pristima®, Xybion’s legacy PATH/TOX SYSTEM and other third party data management systems such as those used for toxico-kinetic data management.

Download -Infographic on The Path to SEND compliance

Xybion designed the Savante™/SEND component to rigidly adhere to the current CDISC standards. As an Associate Member of CDISC™ (Clinical Data Interchange Standards Consortium), Xybion has a thorough understanding of the requirements and best practices. Additionally, working in close cooperation with a large CRO client to identify value add capabilities, Xybion has developed the Savante/SEND module with a transfer mechanism to facilitate the exchange of data between the CRO and the sponsor.

Pristima® and PATH/TOX SYSTEM customers benefit from a seamless integration of these application suites and a friendly user interface that provides the user with guides and queues to complete the submission.

The Pristima® Suite is a comprehensive Research and Safety Study Management application. The system offers advanced capabilities for toxicology and pathology data management. Pristima® VM delivers extensive capabilities for Vivarium Management and Veterinary Care. This unique solution delivers key features that effectively bridge the gap between the business, animal management and scientific aspects of research absent in many of today’s pre-clinical solutions. Pristima® VM’s rich graphical user interface and detailed reports and visualizations deliver the most comprehensive animal facility solution.