FDA's National Center for Toxicological Research (NCTR) Awards Xybion a Multi-year Contract for the COTS Pre-Clinical Data Management System Software
LAWRENCEVILLE, N.J., Oct. 18, 2019 /PRNewswire/ — Xybion Corporation, a US-based leading global technology provider for companies operating in the highly regulated industries, announced today that U.S. Food and Drug Administration’s (FDA) National Center for Toxicological Research (NCTR) awarded a multi-year contract to Xybion. After a competitive RFP process titled “COTS Pre-Clinical Data Management System Software” NCTR selected Xybion’s Pristima XD for various toxicology functions and Savante for producing CDISC SEND format data to replace the organization’s existing data management system with a modern, integrated and comprehensive solution.
Xybion’s Pristima XD and Savante were selected through FDA’s competitive sourcing program amongst multiple vendor proposals and the award includes licensing, implementation and validation services, utilizing Xybion’s expert staff to install, train and validate the Pristima Suite at NCTR. Dr. Pradip K. Banerjee, Chairman and CEO of Xybion said, “We are delighted to have the privilege of working with FDA’s NCTR division to support its mission of promoting and protecting public health of our country.” Dr. Banerjee further stated, “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.”
Scope of the awarded contract includes:
- 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
- System validation
“We are thrilled to partner with the FDA and welcome its scientific team to the Xybion Pristima community. We are excited to deliver industry-leading study management, informatics and analytics solution to NCTR to facilitate and expedite the research of innovative new products and medicines,” stated Kamal Biswas, Xybion’s President and COO.
Xybion is a leading SaaS company dedicated to providing life sciences and health systems companies with innovative software solutions to accelerate the transformation of today’s inventions into tomorrow’s approved medicines, devices, and diagnostic tests designed to save lives and keep employees safe. Our intelligent cloud platform and software solutions help companies accelerate digital transformation of processes, speed up innovation, optimize operations, reduce compliance risks, and achieve significant cost savings. Xybion is serving over 160 customers in 25 countries including all the top 20 global biopharmaceutical companies.
Xybion’s global scale and expertise brings employees around the world to help companies in life sciences, health systems, research institutions, and governments. We put over 40 years of expertise in action every day to help companies digitally transform their regulated business operations. Our unique solutions focus on employee health and safety, integrated preclinical lab management, early-stage drug discovery, digital lab solutions, regulatory compliance, GRC, quality management, predictive compliance, content management, and systems validation.
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