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Study Design

The Pristima® Suite provides a complete Study Design module as part of its pre-clinical data management solution. The study director is often challenged to manage the various teams that work on the study and to monitor the daily activities and results.

Pristima® 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 e-mail, and amendments to the protocol are effective immediately upon approval.

Study Design Module Features and Benefits:

  • 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 pre-clinical 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.

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