Drug Safety Alliance to Advise Society of Quality Assurance Professionals

Joe Knight-McKenna to Speak at SQA Annual Meeting in San Diego

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Drug Safety Alliance (DSA), a global leader in pharmaceutical safety and pharmacovigilance, announced that Joseph Knight-McKenna will present details on auditing electronic data capture software/service vendors at the Society of Quality Assurance (SQA) annual meeting in San Diego, CA on Wednesday, April 22, 2009. Knight-McKenna, Drug Safety Alliance's senior director of quality and regulatory compliance, is a nationally recognized thought leader in the field of pharmacovigilance and has presented on a wide variety of quality assurance (QA) topics at conferences across the country.

"Clinical researchers are utilizing Electronic Data Capturing (EDC) systems more frequently and quality assurance professionals are being asked to audit EDC software /services vendors," said Joe Knight-McKenna, BSN, MBA, CQM/QE, CQA, RAC. "By auditing EDC systems, quality assurance professionals can ensure that their software and software vendors are performing the critical functions they are tasked with and ensure that all of the necessary data is captured correctly during important clinical research trials."

In Knight-McKenna's presentation, he will explain the differences between utilizing a software vendor versus utilizing a service vendor. Auditing these two different types of vendors (software as a product vs. software as a service) entails different criteria and expectations.

"Quality assurance is a central focus to pharmaceutical companies and a rigorous QA program is something Drug Safety Alliance is committed to upholding," Cathy Stokes, chief executive officer of Drug Safety Alliance said. "We are honored that Joe's expertise in performing audit reviews has been recognized by the professionals in the quality assurance realm."

About Drug Safety Alliance

Founded in 2000, Drug Safety Alliance (DSA) provides pharmacovigilance expertise to large and small pharmaceutical and biotechnology companies to ensure 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 adverse event case management, risk management, global regulatory compliance, and safety database hosting and support. DSA is headquartered in the Research Triangle Park region of North Carolina with strategic partnerships worldwide. For more information please visit www.DrugSafetyAlliance.com.