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Software Solution facilitates Conversion of Data From Any Source System Into SEND Format, Streamlining Submission Process
CONSHOHOCKEN, PA -- (BUSINESS WIRE) - Feb. 3, 2006 - Instem, a leading global information solutions provider, today announced the launch of submit™, a joint solution developed by Instem and the PharmQuest Corporation of California. Submit™ is a fully integrated Non-Clinical solution that supports the Food and Drug Administration's (FDA) adoption of a standardized format for collecting, organizing and exchanging non-clinical research data.
The Standard for Exchange of Non-Clinical Data (SEND) focuses on toxicology studies, and utilizes the same principles and rules that were developed for clinical data interchange by CDISC (Clinical Data Interchange Standards Consortium).
The submit™ solution is a fully scalable set of software modules that facilitates the conversion of data from any source system into SEND format. Submit™ tools further enable the FDA, sponsors and their partners to visualize and analyze SEND formatted data on-demand through an intuitive Web-based system. This module, known as ToxVision™, was developed in collaboration with the FDA for their reviewers to analyze and process study data submitted by the pharmaceutical industry.
Instem and PharmQuest will be officially releasing the submit™ solution at this year's Society of Toxicology (SOT) show in San Diego, California in March. The submit™ pavilion, found at booth #1431, will feature live demonstrations and offer organizations the opportunity to speak with Instem-PharmQuest staff about the SEND initiative and the submit™ solution. Instem and PharmQuest will also be announcing their first customer at the show.
"Organizations are now able to move forward in support of the SEND initiative and submit their studies electronically with the confidence of being backed by the combined talents of the two most authoritative resources in the market today," commented Mike Harwood, Senior Vice President at Instem.
By providing one synergistic system, Instem and PharmQuest are empowering organizations to streamline their data acquisition and data submission systems cost effectively. The submit™ solution also extends to smaller organizations who may not be in a position to purchase an on-site system. These organizations can simply send their data on disc and it will be returned in SEND format.
"For many organizations that are trying to predict what they should build and when, submit™ gives them the confidence that they will be SEND-enabled utilizing FDA and industry-driven technology," said Seema Handu, CEO of PharmQuest. "Submit™ will not only streamline their internal processes, it will enable the efficient exchange of information between development partners during the lengthy and costly drug development process."
Those interested in becoming SEND-enabled can either stop by the submit™ pavilion at the SOT show at booth #1431 or request a virtual demonstration over the Web by sending an email to submit@instem-lss.com.
Instem is a world-leading information solutions provider for the Life Sciences - accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products.
Established in 1969, Instem has offices in the United States and Europe with its solutions supported in thirteen countries. Instem serves large multi-national corporations and smaller organizations in overcoming the challenges of managing information and provides solutions that help them further their missions while creating a competitive advantage. For more information on Instem and its solutions, please visit www.instem-lss.com or contact them by email at info@instem-lss.com.
PharmQuest Corporation is a leading provider of SEND enabling technology and the only CDISC registered solution provider for SEND related products. PharmQuest and FDA have entered into a CRADA (Co-operative Research and Development Agreement) to develop standard data evaluation and review tools for electronic submission of safety data. PharmQuest has led the SEND (Standard for Exchange of Nonclinical Data) Consortium since its inception in 2002. PharmQuest's ToxQuest™ family of products is being used by the industry to submit study data in SEND format to the FDA. PharmQuest's ToxVision™ was developed in collaboration with the FDA reviewers to visualize and analyze SEND formatted data. PharmQuest Corporation is headquartered in California. For more information on PharmQuest, please visit www.pharmquest.com
Gary E. Mitchell, VP Global Marketing, Instem US HQ
Tel: (610) 941-0990
Email: gary.mitchell@instem-lss.com
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