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DSA, a global leader in pharmaceutical safety and pharmacovigilance, announced major hardware and software upgrades to support the implementation of the new Empirica Trace adverse event reporting software.
Information Technology Improvements Support Implementation of Enhanced
Adverse Event Reporting Software
(Research Triangle Park, N.C.) - October 30, 2008 -- Drug Safety
Alliance (DSA), a global leader in pharmaceutical safety and
pharmacovigilance, today announced major hardware and software
upgrades to support the implementation of the new Empirica (TM) Trace
adverse event reporting software. The announcement was made as DSA
Chief Information Officer Doug Hill presented a case study on the
upgrade at the Seventh Annual International Users Conference in San
Francisco sponsored by Phase Forward, developers of the software.
Drug Safety Alliance is one of the first companies utilizing Empirica
(TM) Trace, which allows pharmaceutical drug developers and other DSA
clients to collect, code, analyze, and report adverse events during
clinical trials and post-marketing to meet regulatory reporting
requirements in the United States and overseas. The new software
replaces Clintrace (TM), a previous version of the software utilized
"This upgrade to support Empirica (TM) Trace will add convenience,
security, and uptime while enabling us to improve efficiency," said
Hill, adding clients will notice improvements at the user level such
as an improved electronic submissions module.
According to Hill, DSA started working with Phase Forward in November
of 2007 on issues such as moving to windows authentication and
performing necessary hardware changes, having performed risk and gap
analysis on the software in April of this year.
"I'm proud of the work our team has done to take this technology to the
next level," said Cathy Stokes, CEO of Drug Safety Alliance.
In addition to employing secure, state-of-the-art information
technology infrastructure to support database mining, collection and
reporting software like Empirica (TM) Trace, DSA's information
technology department provides data consolidation services and offers
secure database hosting options, acting as a virtual IT department for
clients. The IT services offered by DSA complement the company's
well-established pharmacovigilance practices.
About Drug Safety Alliance
Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance
expertise to large and small pharmaceutical and biotechnology
companies to help them develop safe drugs and improve patient safety.
DSA's mission is to partner with clients to mitigate their drug safety
risks and to maximize product longevity and value. Driven by the
highest ethical standards, DSA is uniquely focused to provide
high-quality pre- and post-market drug safety services including
domestic and international regulatory compliance, safety database
support and hosting options, risk management and adverse event case
management. DSA is headquartered in the Research Triangle Park region
of North Carolina with strategic partnerships worldwide. For more
information please visit www.DrugSafetyAlliance.com.