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Xybion Announces Pristima Selected by Pfizer Inc. for its Drug Safety R&D Data Management Solution

Xybion Corporation announced today that Pfizer Inc. (NYSE:PFE) has selected Xybion’s Pristima Suite to manage its global Drug Safety R&D (DSRD) data management operations. Pristima, a complete off-the-shelf turn-key solution, is a Software as a Service (SaaS) model that consolidates several systems and applications into a single, global solution.

Under the terms of the agreement, Pfizer will implement a suite of Pristima modules for DSRD data management and reporting of toxicology studies. Licensed modules include the Pristima SEND module to support CDISC regulatory electronic data submission and Pristima Savante™ to aggregate, analyze and visualize data from a central data repository (CDR).

As a large component of the project, Xybion will provide a number of services for Pfizer’s implementation of Pristima, including the utilization of Xybion’s services to facilitate Pristima validation. Pfizer may also leverage Xybion’s training and implementation services to train personnel and configure Pristima to meet Pfizer’s best practices and reporting specifications.

Dr. Pradip Banerjee, CEO at Xybion stated, “Xybion is delighted to welcome Pfizer to our client community and we are energized and excited to deliver on this global project. We recognize that Pfizer was a significant contributor to the requirements and conceptualization of Pristima, so it is extremely satisfying to see Pfizer has selected Pristima for its DSRD data management operations.”

Key Facts:

  • Multi-year agreement with online deployment project beginning in 2014
  • Competitive evaluation conducted and Pristima selected utilizing Xybion’s SaaS model
  • Agreement includes Pristima’s In-vivo, Clinical Pathology, Pathology, Statistics and Reporting Modules
  • Licensed Pristima modules also include Pharmacy, Histology, SEND and Savante™, all of which extend Pristima’s leading functional advantages
  • Pristima delivered as a SaaS model can reduce support costs and IT requirements while supporting a hypercare customer service strategy option

ABOUT XYBION

Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Our unique solutions focus on integrated preclinical lab management, early-stage drug discovery, regulatory compliance, GRC, quality management and systems validation.

Xybion's combination of software, business process management, services, validation and staffing enables us to cover a broad spectrum of critical business needs for companies and we deliver our solutions on global scale. Our leadership in this dynamic and ever-changing industry has been a cornerstone of our high-value reputation. To learn more, please visit www.xybion.com.

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