Drug Safety Alliance Advocates Proactive Signal Detection

December 8, 2008

Company News Release

Drug Safety Alliance (DSA) offered details at the recent Seventh Annual International Users Conference in San Francisco, CA on how a well-designed signal management program and select tools can help pharmaceutical companies with early detection of new safety information.

Product Life-Cycle Signal Management Can Help Pharmaceutical Companies Protect Public Health and Product Assets

(Research Triangle Park, N.C.) Drug Safety Alliance (DSA)-a global leader in pharmaceutical safety and pharmacovigilance-offered details at the recent Seventh Annual International Users Conference in San Francisco, CA on how a well-designed signal management program and select tools can help pharmaceutical companies with early detection of new safety information.

In her session, "Pragmatic Solutions and Methods for Proactive Signal Detection" DSA's Chief Safety Officer, Elizabeth Garrard, PharmD, RPh, offered insight into how early detection of possible associations between an adverse event and a drug can help companies recognize and mitigate product risk sooner. Dr. Garrard shared real-world experiences from clients utilizing DSA's enhanced proactive signal detection services during her address to approximately 50 drug safety professionals.

"We're seeing a push within the pharmaceutical industry to become more knowledgeable about possible adverse effects earlier in the drug development process," Dr. Garrard said. According to Dr. Garrard, this is due in part to patient and consumer pressure on the industry and regulatory agencies to realize the positive financial and public health impacts of proactive pharmacovigilance such as signal detection.

Drug Safety Alliance utilizes Empirica Signal by Phase Forward as part of its overall traditional and automated signal detection services to
help drug developers detect risk earlier and react faster in deploying effective mitigation strategies. Empirica Signal is a data mining and knowledge management tool providing detection and quantification of safety signals for safety professionals. Drug Safety Alliance recently announced major hardware and software upgrades to support the implementation of database mining, collection and reporting software such as Empirica Signal.

"We are improving our IT infrastructure, software, and processes to ensure that drug developers of any size who have safety concerns can have access to a comprehensive signal management program that includes state-of-the-art data mining and risk management tools," Cathy Stokes, CEO of Drug Safety Alliance said. "In addition to our strong IT department, DSA employs highly skilled program managers that carefully use these tools. DSA program managers have an average of five years experience in the pharmaceutical industry, which is a lot in a relatively new industry like pharmacovigilance. At Drug Safety Alliance, our ultimate goal to help drug developers ensure regulatory compliance and better serve the public health."

Drug Safety Alliance's risk management strategy complies with current regulation and guidance and is customizable to conform to client need, with services including signal detection; trend analysis; Risk Management Plan and Pharmacovigilance Plan development; Product label review; and development of Risk communication materials.

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.