Pristima®-The Complete Market-Leading Preclinical Software Platform
The Pristima® Suite™ is the industry’s leading preclinical software platform. For 35 years, global pharmaceutical companies, biotechnology firms, and contract research organizations (CROs) alike have relied on the Pristima(Preclinical Software) for effective, end-to-end preclinical data capture and process management.
Pristima is a fully integrated enterprise solution for preclinical data management that delivers complete life cycle automation and support for Pharmacology and Drug Safety Research Study Management, Vivarium Management, and Veterinary Care. From breeding and ordering through the study submission process, the Pristima® Suite manages the planning and recording of data, controls authorized changes, and assembles the data for submission to regulatory agencies.
Explore the modules of Pristima -Preclinical Software – click on an icon to explore that module
As a comprehensive Research and Safety Study Management application, Pristima 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 preclinical software solutions. Pristima VM’s rich graphical user interface and detailed reports and visualizations deliver the most comprehensive animal facility solution.
Key Features and Benefits:
- 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
- The Pristima® suite offers numerous modules, which allow you to select a targeted combination of functions to meet your specific organizational requirements and workflows.
Other notable features include:
- Ability to promote centralized and harmonized study management and data capture. The Pristima® Suite is designed as a fully integrated pre-clinical 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 Labwise platform, you can promote quality data management and 21CFR11 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 enterprise content management (ECM) and compliance infrastructure
- Support for testing and validation
- Reduced IT support costs due to system consolidation and application landscape simplification
- Integration By Design. The Pristima® Suite 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® suite 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 the Pristima Suite™ with enterprise quality management solutions such as eQCM, enabling preclinical laboratories to work seamlessly with internal quality and compliance initiatives.