Thursday, December 26, 2024

Thursday, December 26, 2024

FDA engages software vendor Xybion for data management


https://xybion.com

The U.S. Food and Drug Administration's (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion, a software and consulting firm that will aid in expediting research of new products and medicines.

The contract was awarded following the "COTS Pre-Clinical Data Management System Software" sourcing process. Xybion's Pristima and Savante software services will provide the FDA with study management and in-vivo data management for general and reproductive toxicology, clinical pathology management, necropsy and pathology management, pharmacy inventory and formulations, SEND dataset production, ECTD Tables production, system installation and training, and system validation.

"We are delighted to have the privilege of working with the FDA's NCTR division to support its mission of promoting and protecting the public health of our country," Dr. Pradip K. Banerjee, Chairman and CEO of Xybion, said in a press release. "This is an important win for Xybion, strengthening our commitment to support and improve research and development in the federal government. Xybion is dedicated to providing high-quality and transformational services and solutions to help our customers solve their most complex challenges."

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