QPS-Taiwan Implements Pristima™ Preclinical Data Collection and Management System - May, 2013

Supported by the Xybion validation team, the Center for Toxicology and Preclinical Sciences, CTPS QPS-Taiwan, has launched Xybion’s Pristima™ - a fully integrated preclinical data collection and management system compliant with Title 21 CFR Part 11 Section 11.1 (a). This system will capture, manage and report the toxicology and pathology data for all studies conducted at CTPS. The management team anticipates a tremendous benefit for toxicology testing at CTPS as Pristima™ is specifically designed to reduce errors, enforce data integrity and all but eliminate the quantity of day-to-day paperwork toxicology studies entail. Instead of recording data on paper, key-entering it into Excel and reviewing these data entries daily for mistakes, scientists and technicians will be able to concentrate on science. By allowing staff to record data once, directly to a secure, enterprise-grade Oracle database, and having summarized reports immediately available to the study director, we expect leaps in staff efficiency and customer satisfaction.

The Pristima™ system will benefit most departments of CTPS from Study Management to QA/QC, Toxicology, Clinical Pathology and Pathology. The Pristima™ study protocol, defined and approved prior to study initiation, immediately draws on pre-test data. Pristima™ provides a stratification algorithm to assign subjects to dose groups, and then tracks recurring in-vivo assessments such as body weights, food and water consumption, clinical observations, dose administration, blood and urine collection and even the data review/approval process. Additionally, clinical pathology equipment (for hematology, clinical chemistry,

coagulation and urinalysis) is electronically interfaced to Pristima™ so that sample analysis data are transmitted directly from each instrument to the database. These results are subject to quality management rules enforced by Pristima™; any questions that arise are immediately addressed by a designated staff member upon review. Upon electronic approval of the data, summary reports are immediately available. These include embedded statistical analyses and associated footnotes identifying any significant differences among the dose groups. This quick turn-around on data capture-to-reporting will enable the QPS study director to provide better and faster support to the sponsor’s study monitor.

The QPS team carefully considered market options and deployment strategies and found that Xybion’s Pristima™ software-as-a-service model was the most appealing data management solution. Pristima™ is deployed in a secure, validated data center in Singapore on Xybion’s hardware, thus eliminating immediate expenses incurred for IT infrastructure or third-party software such as Oracle. This model nonetheless will allow QPS to eventually transfer the database into our own infrastructure if our needs change; this combination of flexibility and cost containment was a big factor in our selection.

Now, at the completion of the last stage of validation and training, our staff is energized and anxious to perform all studies using Pristima™.

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