Center for Pharmacology Research of Certi Foundation has Licensed Pristima with the Integrated Labwise™ Module, an “out-of the-Box” GLP, QA Audit Solution

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Xybion's Pristima Suite continues on high growth curve and unveils unique new GLP module for popular preclinical solution.

Xybion announced today that the Center for Pharmacology Research (Centro de Referência em Farmacologia) of Certi Foundation (Fundação Certi) in Florianapolis, Brasil has licensed Pristima® with the integrated Labwise™ module offering an “out-of the-Box” GLP, QA Audit solution for lab operations. After careful evaluation of competitive products, Certi selected Pristima® as the best solution for all of its preclinical data management and reporting. The integrated Labwise™ module in Pristima® makes it the optimal enterprise solution; it addresses toxicology requirements along with SOP management, deviation launching and tracking, master schedule maintenance, and document management in general.

Utilizing Xybion’s standard validation package to accelerate the validation and implementation project, Certi will deploy the General Toxicology, Clinical Pathology, Pathology and Formulations modules for its teams. Xybion will provide web-based and on-site services including installation, configuration, and training in Portuguese. The Labwise™ module, now integrated into Pristima®, streamlines processes and workflows while providing automated features that facilitate audits and require notifications and electronic signatures on issues such as deviations.

Carlos Frade, Xybion’s vice president of R&D Solutions was quoted “I proudly welcome Certi Foundation to our client community. By providing Pristima® in a dual language English/Portuguese deployment, we expect that the Certi staff will quickly adopt and gravitate to using Pristima®, thus expediting the realization of a return on investment for Pristima®. The Labwise™ module of Pristima® provides a quality and tracking feature unmatched by any other product in this space.”

Dr. Pradip Banerjee, CEO at Xybion stated “Pristima® now enjoys a client community across 14 countries on 5 different continents and can be installed out-of-the-box to run in English, Chinese, French and Portuguese. Xybion’s footprint continues to expand rapidly, and we see Certi as the first of many opportunities in South America. The ability to address so many different study types in such diverse languages is really a testament to the talents and visions of Xybion’s engineers.” Dr. Banerjee went on to say that “the full integration of the Labwise™ module into Pristima® adds yet another dimension to the mix of teams served by Pristima®. Now, along with the Toxicologists and Pathologists, the QA group is fully served by a Pristima® module. Designed to meet the diversity in requirements presented by our community, Xybion’s solutions provide tremendous flexibility in the market.”

Certi’s choice to implement Pristima® supports its ongoing commitment to expand and to provide the highest-quality scientific services. With a facility of approximately 60,000 square feet, Certi’s core competencies include performing general toxicity, safety pharmacology, reproductive toxicology, pharmacokinetic and pharmacodynamic studies along with other preclinical study types.

About Certi Foundation
CERTI Foundation is a private, non-profit organization for research, technological development and specialized services that provides innovative solutions to the private sector, government and other research sectors.
With its accumulated experience since 1984 in Environment Science, Technology and Innovation in Brasil, Certi provides services and develops products, systems and processes, combining our skills in structured Research Centers in Innovative Technology focused areas - working in synergy and cooperation with partner entities of the country and abroad.

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.

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Dale Curtis
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