Drug Safety using SAS^® Patient Safety

In the Spotlight SAS® Patient Safety Comprehensive safety reporting and signal detection Regulatory authorities, patients, healthcare professionals, government officials and the media are increasing their scrutiny of drug safety based on continuing, high-profile patient safety issues. Now more than ever, healthcare professionals and patients must continuously evaluate risks against benefits when making decisions about the right therapy. SAS Patient Safety is a comprehensive safety solution that features safety reporting, signal detection, and root cause analysis in a single offering. While less rigorous analytics work for certain applications, the critical nature of patient safety demands the best analytics available. Benefits Reduce your programming and validation efforts. Standard safety analyses address FDA guidance on drug safety information and leverage CDISC implementations that produce standard safety reports and provide the flexibility to adapt quickly to changing regulations. Mitigate potential late-stage development failures and post-marketing risks. Identify and evaluate true pre-approval safety signals so you can make better, more informed drug development program decisions. Efficiently produce PSUR submissions. SAS Patient Safety lets you efficiently and comprehensively produce Periodic Safety Update Reports (PSURs) for submission to the FDA. Achieve the highest level of post-approval safety reviews. Implement a standard set of signal detection algorithms and take a proactive approach to emerging post-market safety concerns. Respond rapidly to inquiries and media events. SAS delivers the most complete scientific information available in order to minimize revenue erosion, protect shareholder value and maintain the public trust. Features Standard safety reporting, which leverages CDISC standards to meet the FDA’s Good Review Practices. Automated signal detection and analysis accelerator, which include these advanced analytical methods: PRR – proportional reporting ratio. ROR – reporting odds ratio. MGPS-EBGM – multigamma Poisson shrinker – empirical Bayes geometric mean. BCPNN-IC – Bayesian confidence propagation neural network – information component. ARS – Adjusted residual score Directed inquiry, with the integrated capabilities to address safety concern issues accurately, efficiently and comprehensively. Comparator analyses for differentiating your therapy’s safety profile from your competitors’ products. Sophisticated data visualization capabilities that go beyond simple tabulations of p-values and frequencies to enable researchers to explore and understand patient safety like never before. Data aggregation and integration capabilities that work with virtually any data source. The SAS Difference World-class analytics. While less rigorous analytics work for certain applications, the critical nature of patient safety demands the best analytics available. Common life sciences platform. Built on the award-winning and enterprise-class SAS®9 architecture, SAS Patient Safety can be integrated with SAS Drug Development and SAS for clinical data integration. Implementation expertise. Experienced SAS® Professional Services® experts are available to assist with your safety implementation. Experience. For over 30 years, SAS has been used to analyze and report safety and efficacy for medical products. Hosting. Optional SAS hosting of the SAS Patient Safety solution allows a quicker implementation, without causing additional strain on an organization’s internal IT infrastructure and resources.

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