BI Solutions : Drug Safety using SAS® for Patient Safety

Business Intelligence BI Software Applications for Life Sciences - Drug Safety using SAS® for Patient Safety

A comprehensive safety solution featuring safety reporting, signal detection and root cause analysis in a single offering

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 for 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 for 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.

Source: Business intelligence BI software applications, SAS BI solutions for life sciences information at sas.com