Pristima - Standard for Exchange of Non-Clinical Data (SEND) Software
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's Pristima is a registered solution provider for CDISC and can ensure your studies are SEND Compliant.
Pristima Suite, the Total Preclinical Lab Management Solution, 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 Team for non-clinical data collected from animal toxicology studies is the FIRST fully integrated end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the pre-clinical research process. From breeding and ordering through the study submission process, the Pristima Suite™ delivers essential capabilities across the entire drug discovery process to facilitate your entire research program. For over 25 years, global pharma companies and CROs have relied on our flagship Pristima pre-clinical data management suite for effective, end-to-end processes. Pristima delivers quality, efficiency, and compliance assurance.
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.