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Charles River Laboratories Preclinical Services Montreal Chooses Instem-PharmQuest submit™ Solution For FDA's SEND Standard

Submit™ Software Solution facilitates Conversion of Data From Any Source System Into SEND Format, Streamlining Submission Process

CONSHOHOCKEN, PA -- (BUSINESS WIRE) – Feb. 10, 2006 - - - Instem, a leading global information solutions provider, today announced that Charles River Laboratories Preclinical Services Montreal, Inc., has purchased the submit solution in response to the Food and Drug Administration’s (FDA) Standard for Exchange of Non-clinical Data (SEND) initiative.

This standardization in an electronic format supports the FDA’s Critical Path Initiative, which is focused on safely bringing medical breakthroughs to patients more efficiently and cost-effectively.

Submit, a joint solution developed by Instem and the PharmQuest Corporation, is a fully integrated pre-clinical software solution that facilitates the conversion of data from any source system into SEND format. The tools further allow the FDA, sponsors and their partners to visualize and analyze SEND formatted data on-demand through an intuitive Web-based system.

Charles River's customer base includes major pharmaceutical and biotechnology companies worldwide as well as leading academic institutions and government research centers.

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 to Instem and it will be returned in SEND format.

Instem has established itself in the Toxicology marketplace as the developer of ProvantisÔ - the industry-leading software system designed for companies engaged in non-clinical safety evaluation studies. Instem’s customer base includes the leading pharmaceutical, chemical and contract research organizations across sites worldwide.

About Charles River Laboratories
Charles River Laboratories, based in Wilmington, Massachusetts, U.S., is a global provider of solutions that advance the drug discovery and development process. Our leading-edge products and services are designed to enable our clients to bring drugs to market faster and more efficiently. Backed by our rigorous, best-in-class procedures and our proven data collection, analysis and reporting capabilities, our products and services are organized into three categories spanning every step of the drug development pipeline: Research Models and Services, Preclinical Services, and Clinical Services. Charles River's customer base includes all of the major pharmaceutical companies and many biotechnology companies, government agencies and leading hospitals and academic institutions. Charles River's 8,500 employees serve clients in more than 50 countries. For more information on Charles River, visit our website at www.criver.com.

Organizations interested in becoming SEND-enabled can either stop by the submit pavilion at the SOT show in San Diego at booth #1431 in March, or request a virtual demonstration over the Web by sending an email to submit@instem-lss.com.

About Instem
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.

About PharmQuest
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 non-clinical safety data. PharmQuest has led the SEND (Standard for Exchange of Non-clinical 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

 

 

 

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