Leading Biopharmaceutical Organization Selects Instem’s SEND Software Suite
New Instem Client Chooses submit™ and SENDView™ SaaS Deployment to Ensure SEND Compliance
CONSHOHOCKEN, PA – September 20, 2016 - Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that a specialty-focused, research-based biopharmaceutical company headquartered in the United States has purchased Instem’s submit™ software solution suite. The company has selected submit to generate and manage SEND (The Standard for Exchange of Nonclinical Data) compliant data and documents.
The new client evaluated a range of SEND management tools on the market, including those provided by their existing preclinical IT vendor. Instem was selected because of their SEND leadership position and submit product functionality, especially the ability to extract data from the organization’s 3rd party preclinical data management system and create SEND datasets
- 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 purchase includes Instem’s SENDView™ application for simplified QC review
- Client to access submit and SENDView using Instem’s SaaS delivery model
- The organization has signed a multi-year subscription agreement with Instem.
In December 2014, the US Food and Drug Administration issued a binding guidance implementing the electronic submission requirements for study data in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologic licensing applications (BLAs) and investigational new drug applications (INDs). The guidance points to standards specified in the Data Standards Catalog, including SEND for non-clinical data, with an implementation date of December 17, 2016. This new client will be fully SEND enabled and well prepared for this year’s FDA SEND deadline.
Gary Mitchell, Vice President of Marketing at Instem, said, “We are delighted to welcome another client to our SEND-submit client roster; they will be joining the largest and fastest growing SEND-enabled community in the world. Their use of submit and SENDView will help them to meet the impending FDA SEND deadline and solidify their SEND capabilities moving forward.”
The submit platform provides a suite of integrated tools and services for the creation and management of SEND datasets and associated documents. Instem developed submit, the first commercially available SEND software solution in 2005 and it is now the most widely adopted in the market, supporting over 45 client sites across 15 countries. The submit platform is 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.
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