Study Design

The Pristima® Suite provides a complete Statistical Analysis module as part of its preclinical data management solution, minimizing or eliminating the need for third party statistical analysis. The module includes a comprehensive set of commonly used bio-statistics tools, with detailed reporting of interim test results.

Xybion’s Study Manager Software enables the study director to detail all aspects of the study protocol and to define all activity schedules, providing the most integrated approach of any system available today. Approvals are electronically documented, reviewers are notified by email, and amendments to the protocol are effective immediately upon approval.

Study Design Module Features:

  • Flexible protocol builder, supporting a variety of study designs
  • Support for a variety of workflows, including General Toxicology, Reproductive Toxicology, and Safety Pharmacology
  • Enables quality data management by eliminating the need for data duplication or redundant workflows
  • Manages all of the necessary reviews, approvals, and amendments required
  • Event scheduling at varying levels – for all animals, for individual animals, by group, by gender, by sub-group or litter
  • Scheduling of daily in-vivo measurements, sample collections, sample analyses, necropsy activities, and pathology requirements
  • Full GLP and OECD compliance

About Pristima

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.