CTI Biotechnology Selects Pristima®
MORRIS PLAINS, N.J., June 30, 2015 /PRNewswire/ — Xybion Corporation, leading provider of preclinical R&D solutions announced today that CTI Biotechnology in Suzhou, China has implemented Xybion’s Pristima® 7 Preclinical Suite. Pristima® was selected after an exhaustive evaluation of top selling preclinical software systems on the market. Pristima’s unique, end-to-end solution for the management of preclinical data from compound receipt through study submission stands apart from its competitors and will serve as the foundation for the CTI’s rapid expansion.
CTI Biotechnology is one of the newest and largest preclinical institutions in China and a leading provider of drug development services. To support its expansion efforts in conducting GLP studies, CTI has leveraged Pristima’s full capabilities including Colony Management, General Toxicology, Repro Toxicology, Clinical Pathology and Pathology modules, along with Xybion’s standard validation package. With the use of Xybion’s validation package, training and installation services, CTI has completed a full implementation project in record time.
Located in Kunshan New and High-Tech Development Zone, the facilities of CTI Biotechnology (Suzhou) covers 46700 sqm. The laboratory is designed to international Good Laboratory Practice (GLP) standards and relevant state regulatory requirements and equipped with advanced scientific instruments equipment covering researches in toxicology, pathology, clinical testing, analytical testing and related fields. Pristima was carefully selected to provide the automation and scalability to support a fast-growing organization that is dedicated to continuous improvements in productivity and quality while reducing the labor and time to generate the final report for submission.
Dr. Li Wang, Director of CTI Biotechnology stated that “there were great expectations both functionality and speed of validation for Pristima. Given the ambitious project timelines to implement Pristima and incorporate it as a key component of our GLP business, it was important to have both the validation support and product quality to accomplish this project. We found that Pristima was a great match for our needs and have performed the implementation according to our aggressive plans.” Dr. Wang added, “We have developed a very comfortable working relationship with Xybion.”
With over 4000 licensed users in Preclinical Laboratories in 14 different countries on 5 continents, Pristima is the most modern and flexible enterprise data management system for safety assessment; facilitating the user compliance by supporting the user’s native language for data entry and generating reports in either the native language or in English.
Xybion’s CEO Dr. Pradip Banerjee commented, “We are very excited to add CTI Biotechnology to our growing global family of Pristima clients and we work continuously to make Pristima the solution-of-choice within the China market and we are doing so by combining the most feature-rich solution with high quality product services on a 24 hour basis.”
About CTI Biotechnology
Invested by Centre Testing International Corporation (SZ: 300012), CTI Biotechnology (Suzhou) Co., Ltd is a Contract Research Organization (CRO) company for pre-clinical research for new drugs, providing experiment facilities and services in screening, development, pharmacodynamics research and safety evaluation and testing of new drug for pharmaceutical enterprises and research organizations. CTI Biotechnology conducts safety evaluations of new drugs (Biotechnology-derived Pharmaceuticals, small molecules, Traditional Chinese Medicine and Biomaterials) and provide regulatory submission materials.
http://www.cti-cert.com.hk/
ABOUT XYBION
Xybion is a 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.
About Pristima
The Pristima® Suite is a fully integrated, end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the preclinical research process. From ordering through the study submission process, the Pristima software platform delivers essential capabilities across the entire drug discovery process. The system enables organizations to maintain all preclinical data in one system, from compound receipt through dossier submission and slide archival. For over 35 years, global pharmaceutical companies and CROs have relied on Xybion to drive data management while ensuring quality, efficiency, and compliance.
