Download: Whitepaper ‘Safety signal detection based on AERS data’
Sciformix is a knowledge based global service provider for the Pharmaceutical and Biopharmaceutical industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Biometrics, Scientific Writing, and Regulatory Affairs.
Their signal detection and signal management services employ both qualitative and quantitative methods to identify signals and anticipate potential risks so as to propose and implement solutions that maximize the benefit of the drug while proactively managing its safety. Their safety specialists and regulatory strategists will help you identify potential regulatory concerns and will help you address them comprehensively by developing a Risk Management Plan.
They have kindly provided a whitepaper titled ‘Singulair: Safety signal detection based on AERS data’ for you to download.
As the premium sponsor, Sciformix will be hosting a breakfast seminar session at World Drug Safety Americas titled ‘Taking the noise out of signal detection – Illustration of a New Method and panel discussion’, find out more about the session here. The abstract for the session is as follows ‘Users of signal detection methods have experienced inadequacies of available quantitative measures to accurately and robustly detect safety issues. In this session a team of medical and scientific experts will discuss these pitfalls and present a new method based on the likelihood ratio test. This interactive session will provide a demonstration of this method and compare its performance relative to other available methods. Experts will provide practical solutions, lessons learned and indicate possible enhancements of the method during an informative and thought provoking presentation and panel discussion.’
Don’t forget to download your copy of the whitepaper here.
