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.
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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® SEND Conduit (SCC) is fully integrated with the full Pristima® Data Management Suite is designed to comply with the FDA regulatory guidelines and standards. Acting as a channel to concentrate and reformat preclinical data, the Pristima® SCC module is designed to support 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 toxicokinetic data management.
Xybion designed the SCC module 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 SCC module with a transfer mechanism to facilitate the exchange of data between the CRO and the sponsor.
The Pristima® and PATH/TOX SYSTEM customer 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.