| DRUG
SAFETY ALLIANCE ANNOUNCES PHARMACOVIGILANCE
UPGRADES
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.
A lively, detailed Q&A session followed
Hill's presentation, with many in the enthusiastic
audience looking to follow DSA's lead in
successfully implementing 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
by DSA.
"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.
Media Contacts
David Menzies
Menzies Consulting, Inc
dmenzies@menziesconsulting.com
(919) 274-6862
Drug Safety Alliance
Deena Wegner
(919) 401-8003
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