The Pristima® Core module (Pristima®) is a fully integrated, preclinical software platform that delivers full lifecycle automation and support for Research and Safety study management, vivarium management, and veterinary care. The Pristima® is the industry’s leading preclinical software platform. For over 40 years, global Pharmaceutical companies, Biotechnology firms, and Contract Research Organizations (CROs) alike have relied on Pristima preclinical software for effective, end-to-end preclinical data capture and process management. From breeding and ordering through the study submission process, the Pristima Core manages the planning and recording of data, controls authorized changes, and assembles the data for submission to regulatory agencies. It establishes a centralized platform for a laboratory animal research facility. It helps streamline the complex data workflows of laboratories and provides a single point of access to research data and functionality to multiple stakeholders.
As a comprehensive Research and Safety Study Management application, Pristima offers advanced capabilities for toxicology and pathology data management. Pristima 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 preclinical software solutions.
- Supports 21 CFR compliance
- Pristima is designed to support compliance with 21 CFR Parts 58 and 11. Its unique design provides built-in flexibility, enabling integration with both GLP and non-GLP compliant laboratory environments
- Integrated and enterprise-ready Pristima is designed for integration of the various roles involved in the research study, including vivarium managers, study directors, animal technicians, formulation scientists, pathologists, report writers, and more
- The entire preclinical workflow is covered end-to-end by one system, with data captured in one global repository. With support for multiple languages, multiple time zones and various study types, Pristima supports data capture across the enterprise
- Modular design offers flexibility
- Pristima offers numerous modules, which allow you to select a targeted combination of functions to meet your specific organizational requirements and workflows
Other Notable Features:
- Ability to promote centralized and harmonized study management and data capture. The Pristima Core is designed as a fully-integrated preclinical data capture and data management solution, allowing you to consolidate study management and data in one place
- Unlimited simultaneous studies. Pristima supports an unlimited number of simultaneous studies and users
- Out-of-the-box instrument integration with over 100 clinical pathology instruments, allowing you to aggregate data from multiple sources
- Streamlined reporting and submission through the delivery of real-time statistical analyses across multiple data sources
- Integrated Quality Management. Through integration with Xybion’s LabwiseTM platform, you can promote quality data management and 21 CFR Part 11 compliance through the use of configurable business rules, security settings, and audit trails
- Pristima provides tools to support research and centralized study management, vivarium management and veterinary care, enabling maximum efficiency in the preclinical environment. The platform streamlines reporting and submission processes through the delivery of real-time statistical analyses across multiple data sources. Providing out-of-the-box integration with over 100 clinical pathology instruments, Pristima enables clients to aggregate and consolidate data capture from multiple sources
- Significant reduction in time to final report and study close-out
- One integrated preclinical platform covering the entire end-to-end preclinical data management process, enabling you to consolidate systems and reduce costs
- Functionality to support business process as well as and study management requirements
- Built-in features to support regulatory compliance with IACUC, AALAC, GLP, 21 CFR Part 11, and internal training requirements
- Seamless integration with data sources and equipment across business functions
- Integrated with Emidence ECM (Enterprise Content Management) and compliance infrastructure
- Support for testing and validation
- Reduced IT support costs due to system consolidation and application landscape simplification
How is Pristima Unique?
- Integration by Design: Pristima Core is designed as a fully integrated preclinical data management system. The modular design of Pristima ensures seamless interoperability throughout the full preclinical lifecycle process for greater efficiency and minimal expensive customization
- Flexible Deployment Options: The power of the Pristima Core is now available in a hosted environment through a Software-as-a-Service licensing model
- Multi-Language Support: Pristima supports both Western and Asian character sets, enabling support for a wide variety of languages, such as English, Chinese, French, German, etc.
- Streamlines Reporting & Submission Processes: Pristima helps streamline reporting and submission processes through the delivery of real-time statistical analysis
- Ensures Data Quality Management: Pristima promotes quality data management at all times through business rules, security and audit trails
- Unlimited Number of Simultaneous Studies: Pristima supports an unlimited number of simultaneous studies and users
- Integrated Quality Management: Xybion has integrated Pristima Core with enterprise quality management solutions such as Labwise XD, enabling preclinical laboratories to work seamlessly with internal quality and compliance initiatives