Xybion and Sinclair Research Center Partner to Automate and Digitize Drug Safety Assessment Operations

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Xybion and Sinclair Research LLC. Team Up to Automate and Digitize Drug Safety Assessment Operations at Sinclair using Xybion’s Total Preclinical Solutions Platform including Labwise, Pristima and Savante SEND

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Xybion Corporation announced today that Sinclair Research Center, LLC will deploy Xybion’s Total Preclinical Solution platform across Sinclair’s entire Laboratory operation. Sinclair and Xybion are collaborating to get ahead of the FDA SEND mandate while digitizing and automating Sinclair’s Lab to achieve significant productivity gains to support the growth of Sinclair’s business.

As a large component of the multi-year program, Xybion will provide a number of services for Sinclair’s implementation of Pristima, Labwise, and Savante SEND module including the utilization of Xybion’s services for training, configuration and to facilitate validation. Sinclair will also leverage Xybion’s training and implementation services to train personnel and configure the Total Preclinical Solution to meet Sinclair’s best practices and growth plans.

“This partnership with Xybion takes our Preclinical research services business to a whole new level of Compliance, Innovation and Productivity”, said Dr. Guy Bouchard, Sinclair’s President. “Xybion’s industry leading Nonclinical Platform Pristima with its laboratory operations management solution Labwise and Savante SEND technology offer us the industry’s first truly integrated solution on a single platform.”

“Xybion’s is excited to welcome Sinclair to our family of leading pharmaceutical, CRO and biotechnology companies leveraging our Nonclinical Laboratory Operations Platform said Pradip Banerjee, Xybion’s Chief Executive Officer. This multi-year partnership will ensure Sinclair’s nonclinical research organization is automated, compliant, efficient and ready for FDA SEND regulations.    

Xybion’s integrated solution is deployed to hundreds of users at Sinclair and represents the core operational platform for all Nonclinical Research Studies.        

Key Facts:
Total Preclinical Solution includes:

  • Pristima fully integrated end-to-end enterprise solution for tracking and managing veterinary facilities and research subjects throughout the preclinical research process.
  • Labwise laboratory operations management solution including SOP, equipment, training and quality management
  • SEND Savante provides a module to facilitate the FDA SEND standards for preclinical submissions.

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 http://www.xybion.com.

Sinclair Research Center offers specialty biomedical research services in a large range of species encompassing most categories of applied human and veterinary medicine. Preclinical research services and preclinical studies compose a significant portion of our repertoire. Our uniqueness includes our broad experience, the availability of multiple animal models, and the largest herds of miniature swine (miniswine, or minipigs) in the United States. We remain flexible and can tailor our efforts to almost any special procedure that is requested or designed. We strive to retain our customers through competitive cost, strong communication, timeliness, and responsive programs. To learn more, please visit http://www.sinclairresearch.com

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