Information Technology Improvements Support Implementation Of Enhanced Adverse Event Reporting Software

Main Category: IT / Internet / E-mail
Also Included In: Pharmacy / Pharmacist;  Pharma Industry / Biotech Industry
Article Date: 04 Nov 2008 - 1:00 PDT

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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 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.

Drug Safety Alliance

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