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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