Early warning system

CSS Informatics, DrugLogic integrate safety data technologies to allow early detection of adverse trial events

Amy Swinderman
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WILMINGTON, N.C.—Clinical and safety data management consulting firm CSS Informatics and drug safety data developer and analysis company DrugLogic will integrate their proprietary technologies with the goal of creating a faster way for research clients to detect and access clinical trial adverse event data, according to the companies' announcement last month.

CSS Informatics will integrate DrugLogic's Qscan technology, which provides safety surveillance and signal detection capabilities, with its Oracle Adverse Event Reporting System (AERS) services, enabling clients to analyze patterns in adverse events that may indicate emerging pre- and post-market drug safety risks. The companies will co-market the product within the Oracle Health Sciences suite, which was successfully executed at the Oracle Clinical Users Group (OCUG), the annual conferences of the Drug Information Association (DIA) and the International Society of Pharmacoepidemiology (ISPE). The deal also involves licensing and re-selling agreements. Financial terms were not disclosed.

Previously, PPD Inc., CSS' parent firm, used Qscan for its sponsor base with the FDA's AERS. Graham Downing, vice president of Informatics at CSS, says the early risk identification capabilities created by the integration will enable faster response times and help to ensure drug safety compliance.

"This integration stands out because it brings together two software packages of choice," Downing says. "In looking at Qscan, we felt it was the leading product in detection of signal management. In the absence of Qscan, people will be able to do pharmacodiligence activities, but they won't have data mining capabilities. The integration of the two products allows companies to analyze data in one place and across many different areas in one company. We will perform the installation, testing and validation and make sure we have full implementation and success before leaving the client's door."

Paul Zapert, vice president of sales and marketing for DrugLogic, agrees the integration promotes best-in-class safety systems.

"CSS has both a technical, IT background and product domain knowledge of Oracle Clinical and Oracle AERS," Zapert says. "By combining the capabilities of Qscan with CSS Informatics' strong expertise in safety integration, consulting and validation, we can help companies looking to understand and respond to adverse event data more quickly."

With the FDA's current focus on drug safety, the companies' clients were in need of a platform that delivered a fast, in-depth understanding of events that could put patient safety at risk, Downing says.

"To an extent, some of the safety concerns are due to a fear of the unknown," he says. "With the ability to mine signals, companies can move faster, gain in-depth knowledge and proactively address and resolve any safety concerns." DDN

Amy Swinderman

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