PharPoint Research, Inc., a drug development service company providing biostatistics and data management services to the pharmaceutical and biotechnology industries, launches ‘Target SAE System’, an electronic solution for the management of serious adverse events (SAE) and the integration of these data with other safety data collected in clinical trials.
‘Target SAE System’ provides the necessary framework to fully integrate SAE management and data analysis thereby providing our clients the ability to perform the necessary aggregate analyses to provide true safety surveillance and informed signal detection”, stated Jennifer A. Elder, PhD, PharPoint Chief Scientific Officer. “The launch of ‘Target SAE System’ is timely as the FDA has called for cooperation and implementation of its ‘Final Rule’ by 28 September 2011.”
Audra McRae, PharPoint Chief Operating Officer commented, “PharPoint is well-positioned to offer this capability. By integrating the serious adverse event reporting component with our vast experience in data management and data analysis, PharPoint places itself in the best position to give our sponsors the timely reporting of individual events as well as the aggregate data analysis they need to ensure compliance with federal regulations.”