Thermo Fisher
Scientific Inc., the world leader in serving science, today announced that International
Pharmaceutical Research Center (IPRC) has implemented Thermo Scientific Watson
LIMS (laboratory information management system) to improve productivity of its Phase
I clinical trials unit while enabling compliance with current regulatory requirements.
Since the implementation of Watson LIMS at IPRC's Phase I unit, the company has
benefited from significant productivity improvements, efficient assay
validation, timely bioanalysis of samples, seamless instrument interfacing,
easy sample tracking and reliable reporting of results.
Watson LIMS is a
highly specialized, protocol-driven LIMS for drug metabolism and
pharmacokinetic (DMPK) studies and is used as standard in bioanalytical
laboratories in 18 of the top 20 global pharmaceutical companies and leading
contract research organizations (CROs). It is designed to benefit
pharmaceutical companies and CROs by offering secure data transmissions between
pharmaceutical sponsor and CROs, helping ensure regulatory compliance, enabling
reliable audit trails and thereby improving time to market.
Founded in Amman, Jordan,
in 1997, IPRC is a privately owned CRO providing effective and reliable
clinical services to the pharmaceutical industry in the Middle East and North
Africa (MENA) region, Europe and the US in accordance with GxP
guidelines and international regulations. To date, IPRC has conducted more than
800 bioavailability and bioequivalence studies and has developed and validated 195
bioanalytical
methods. On a daily basis, a team of dedicated, highly qualified
professionals is required to perform a large number of sample analyses with the
aim of providing pharmaceutical customers with advanced clinical research
results in a timely manner. In order to manage the increasing analytical requirements,
IPRC needed a laboratory information management system that would enable the
company to optimize the reporting of study results while safely archiving all
study-related data. The company selected Thermo Scientific Watson LIMS due to
the system's purpose-built functionality for bioanalytical testing
applications.
The LIMS has
facilitated efficient study design and data transfer between researchers,
enabling IPRC to benefit from improved operational efficiency," said Dr. Isam
Salem, vice president, operations, IPRC. "We also achieve accelerated
laboratory turnaround, reduced costs associated with sample management and
regulatory compliance with GLP and 21 CFR Part 11 requirements."
"We're confident our
informatics solutions can provide IPRC with the tools and securities it needs
to deliver expertise and technically advanced clinical research services in a
timely manner and in compliance with local and international regulations," said
Dave Champagne, vice president and general manager for Informatics at Thermo
Fisher Scientific. "The purpose-built functionality of Watson LIMS has
delivered improved efficiencies and reduced validation time for IPRC,
contributing to significant time and cost savings. This implementation
demonstrates our dedication to providing high level expertise to the Middle East pharmaceutical industry through the strength
and services of our Informatics Global Partner Alliance program, which has been
pivotal in expanding our geographical reach into this important region. Watson LIMS
enables CROs, like IPCR, to realize their goal of becoming strategic partners
with their pharmaceutical customers and facilitates seamless communication with
sponsors."
For more information
about Thermo Scientific informatics solutions, please call +1-866-463-6522 (U.S.),
+44 161 942 3000 (EU) e-mail
marketing.informatics@thermofisher.com
or visit
www.thermoscientific.com/informatics.
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