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WuXi AppTec Selects Instem's Submit™ Software Suite to Meet Growing Demand for SEND

Leading China Based CRO Purchases Full Submit Software Suite for Complete SEND Management

January 17, 2017 - Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that China based Contract Research Organization (CRO), WuXi AppTec (WuXi), will be deploying its submit™ software suite for the creation and management of SEND (Standard for Exchange of Nonclinical Data) compliant datasets.

Established in 2000, WuXi has over 15 years’ experience in providing outsourced R&D services to the pharmaceutical, biotechnology and medical device markets. WuXi’s purchase of submit is in response to increasing customer demand for SEND compliant datasets, as organizations take steps to adhere to the FDA’s SEND mandate which came into force on December 17, 2016.  The mandate states that all organizations must now use the appropriate FDA-supported standards, formats and terminologies specified in the FDA Data Standards Catalog for NDA, ANDA, and certain BLA submissions.

Key Facts

  • WuXi to implement the complete submit software suite for the creation and management of SEND datasets and associated documents
  • WuXi also deploying SENDView™, an Instem tool for simplified QC review of SEND datasets
  • Contract awarded due to comprehensive submit product functionality and Instem’s unrivalled SEND expertise and leadership
  • This purchase follows the recent procurement of the Provantis® Toxicology Resource Planning (TRP) and Business Objects modules, to further streamline preclinical study processes

Dr. Yi Jin, Chief Scientific Toxicologist at WuXi, said “Instem is widely regarded throughout the Chinese R&D sector as the gold standard for IT solutions. We have been working in partnership with Instem since 2009 and over the course of our eight-year relationship we have been continually impressed with their best-in-class solutions and their commitment to customer service. Their experience and global leadership in the SEND domain made the decision to invest in submit a straightforward and logical one.”

Bill Harrison, Head of Toxicology Services, WuXi, added: “In an increasingly competitive market, CROs need to remain flexible and adaptable in order to meet changing market demands, while maintaining regulatory compliance. Here at WuXi, we are actively improving our capabilities and capacity through new expansions in our global business. Our deployment of submit is yet another step in our deep commitment to providing growing, comprehensive support to our clients worldwide and we look forward to providing consistent, high quality, SEND compliant datasets to our Sponsors.”

Neil Donaldson, Vice President of Global Sales Europe & Asia, remarked: “We are honored that WuXi has pledged further commitment to Instem and our solutions. The deployment of submit will help to consolidate WuXi’s position as one of China’s leading CROs, and we look forward to further strengthening our relationship with them as they continue to develop their services to meet the demands of the global R&D industry.”

The submit solution is uniquely meeting the very wide range of demands that span the needs of the largest multi-national pharmaceutical organizations and CROs, to the smallest organizations and their advisors. Submit creates datasets from any electronic source, it then manages SEND datasets throughout their entire lifecycle including the ability to QC Review and perform advanced single and multi-study data visualizations and analyses. Originally developed in 2005, the submit suite of tools and outsourced services is now the most widely adopted SEND solution in the market across 15 countries.

About WuXi AppTec

Serving the global market, WuXi AppTec is a leading pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform. WuXi provides efficient solutions to clients across the globe, helping organizations to bring new medicines and products to market through cost-effective outsourced R&D. Working in both China and the USA, WuXi’s 26 sites in 7 countries are committed to developing an alternative to the traditional R&D model in order to continue to serve and transform the global life sciences market.

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About Instem

Instem is a leading supplier of IT applications and services to the early development healthcare market delivering compelling solutions for data collection, analysis and regulatory submissions management. Instem solutions are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.

Instem’s portfolio of software solutions and consulting services increases client productivity by enhancing product development processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.

Instem supports over 500 clients through offices in the United States, United Kingdom, France, Japan, China and India.

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