Pristima XD

The Gold Standard for Preclinical R&D

Experience It!

Unify the Preclinical R&D and CRO laboratory operating environment, reduce costs and improve productivity

Overview

Introducing Pristima® XD – the Xybion Preclinical Gold Standard Digital Laboratory Execution Solution: an end-to-end digital Laboratory Execution System with workflows, innovative technology-driven automation, connected systems and facilities, and data and information management for the entire preclinical process.

Pristima XD Total Preclinical Solution provides an end-to-end approach to leveraging new technologies with a tested integration information framework, central data repository, and a standardized archive platform.

Transform your entire preclinical R&D process and quality & compliance management

Xybion has combined several proven industry leading core competencies, to create a Total Preclinical Solutions platform to mirror your overall needs:

  • Pristima Core: Preclinical study & data management
  • Pristima Operations & Compliance: An Out of the Box validated Business Process Automation solution based on Xybion’s low-code digital cloud platform with built-in GXP Audit, CAPA, Master Schedule management, training and SOP management system and the Content integration, Migration solution platform that  provides an intelligent information gateway between disparate systems
  • Pristima VM: Complete animal, veterinary, and facility management including IACUC and Census. With compliance-embedded workflows, Xybion’s IACUC Protocol Management Software helps streamline and improve the protocol compliance in adherence to regulations.
  • Pristima Savante™: Standard for Exchange of Non-Clinical Data (SEND) and SEND Intelligence Service, Data warehouse with visualization tools like Spotfire

Preclinical study & data management

The Pristima® Suite 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 Suite 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.

Pristima is a fully-integrated enterprise solution for preclinical data management that delivers complete lifecycle 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.

Operations & Compliance

In addition to supporting operational aspects of R&D such as equipment management, training records, material flows, and deviation tracking, the Pristima® platform offers additional functions to support Laboratory Governance, Risk, and Compliance (Laboratory GRC).

This powerful combination enables organizations to drive operational efficiency while also maintaining oversight, proper governance, and overall compliance in regulated laboratories operating under GLP, GMP, and GCP. This enables you to converge on one platform, resulting in lower cost of ownership, reduced IT complexity, and a more robust solution for today’s laboratory.

Pristima operations and compliance

Vivarium Management

Complete animal, veterinary, and facility management including IACUC and Census. With compliance-embedded workflows, Xybion’s IACUC Protocol Management Software helps streamline and improve the protocol compliance in adherence to regulations.

Supports

  • Compliance
  • Operations
  • Real-time Tracking
  • Animal Management
  • Laboratory Staff

Key Features

  • Global Regulatory Compliance
  • Automated Billing & Invoicing
  • Inventory Management
  • Automated Task Management
  • Team Management
  • Scheduling and Resource Management
  • Animal Room Facility & Vivarium Management
  • Location Management
  • Automated Logistics of Animal Requests & Orders
  • Veterinary & Experimental Records
  • Colony Management

Pristima SEND Submission Management

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 preclinical 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 toxicokinetic data management.

Xybion designed the Savante SEND component to adhere to the current CDISC standards. Pristima data collection 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.

Key Features

  • Consolidation and formatting of study data
  • Data aggregation from multiple sources
  • Automated data collection
  • Flexible data analysis and visualization
  • SEND guidance for the collection of the preclinical study data
  • Secure data transmission between Xybion and its clients
  • Automated transformation of client’s raw data files and import into Savante along with creation of the trial design
  • Automated production of the SEND v3.1 data set including the data domains, Define-XML and Study Data Reviewer’s Guide
  • Internal review of SEND data sets and quality assurance of SEND compliance

 Results

  • Provides the foundation to increase preclinical insights
  • Reducing the ongoing effort and cost to execute and validate the processes and technologies with new or existing systems
  • Visibility to the information where it resides and initiate actions based on the current business requirements with transparency across the various systems
  • A Study Director can readily check on a new compound that is being qualified at multiple sites and automatically initiate a process once a stage gate is reached.
  • Initiate workflows & system processes based on events or end users actions
  • Real-time information dashboard of Merck’s preclinical pipeline

Retire costly legacy systems and realize the benefits that other Xybion customers are experiencing such as a lower total cost of ownership, more accurate and complete regulatory submissions, and a shorter time to market for new drugs and devices

© Xybion Corporation 2020