Leading Japanese Pharmaceutical Organization Becomes SEND-Enabled with Instem's submit™ Software Suite
Japanese Pharma Company Chooses submit™ and SENDView™ to Address Mandatory FDA Requirements for Nonclinical Data
CONSHOHOCKEN, PA – December 2, 2016 - Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that a research-based Japanese life sciences company has purchased Instem’s submit™ and SENDView™ solutions for the creation and management of SEND (The Standard for Exchange of Nonclinical Data) compliant data and documents.
- Client has purchased the full submit™ software platform, a suite of integrated tools for the creation and management of SEND datasets and associated documents
- The company has also purchased Instem’s SENDView™ application for simplified QC review
- Client has signed a multi-year subscription agreement and will access submit and SENDView via Instem’s SaaS deployment model
Neil Donaldson, VP Sales EU & Asia, Instem, said, “We are delighted to welcome this latest client to our growing SEND-submit community. The deployment of submit and SENDView will allow our client to implement SEND quickly for products with FDA submission targets, enabling them to maintain compliance with imminent FDA mandatory submission requirements for SEND, which begin this month. We look forward to working closely with them to automate their SEND capabilities.”
The submit™ platform provides a suite of integrated tools and services for the creation and management of SEND datasets and associated documents. SENDView™ simplifies the review of SEND datasets, enabling the user to view the data and its relationships in meaningful combinations and to easily keep track of their dataset review progress. More information about SEND and Instem’s tools can be found here.
This latest agreement illustrates Instem’s growing SEND leadership in Japan. Instem has been serving the Japanese marketplace since 2005 with its distribution partner CTC Life Science Corp and has embarked on an expansion plan to grow that relationship, while also providing increased direct market support. Instem has recently opened an office in Tokyo, has hired additional staff and has expanded its technology offerings. In June of this year, Instem signed a partnership deal with BoZo Research Center who selected Instem as their SEND outsourcing partner in Japan.
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.
Gary Mitchell (US HQ)
Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600