Speaker: Dr. Michael O'Connell, Director Life Science Solutions, Insightful Corporation
Download the web cast presentation.
Drug safety issues continue to drive headlines up and stock prices down. The past 12 months have seen failure of high profile drugs in late stage clinical trials (e.g. torcetrapib), withdrawal of drugs from market (e.g. Trayslol) and black-box warnings resulting from academic journal articles (e.g. Avandia).
The Insightful Clinical Graphics™ and Insightful Clinical Review™ Solutions are geared towards rapid and accurate analysis and reporting of safety data. They incorporate targeted statistical and graphical analyses for AE’s, labs and vitals; in alignment with FDA safety guidances e.g. the recent Oct 07 guidance on drug induced liver injury (DILI). The Solutions are designed to address sparse data and multiple endpoints issues with safety data.
Insightful Clinical Graphics provides a standard library of statistical graphics for safety data analysis, and enables simple sharing and re-purposing of graphical analyses in user-friendly interfaces and workflows. Built on the S-PLUS Enterprise Server, Insightful Clinical Graphics is scalable to large groups of statisticians, clinicians and programmers.
Statistically sound safety data analyses, and their resulting interactive graphical/tabular review and report outputs, have immense value for pharmaceutical companies, drug safety monitoring boards and regulatory agencies such as the FDA. We invite statisticians, clinicians and management across the industry to join this webcast, and this movement towards better safety data analysis, clinical review and study reporting.
Michael O'Connell runs the Life Science Solutions effort at Insightful. Michael has been working in the medical device, diagnostics, pharmaceutical and biotech arena for the past 15 years. His background and graduate work was in applied statistics and he has published more than 50 papers on statistical methods and life science applications including calibration, mixed models, and nonparametric regression. He has also written several statistical software packages and libraries. More recently he has been active in the development of tools for analysis and reporting of clinical and safety data from
S-PLUS. Michael holds a Bachelors degree in Science from the University of Sydney, a Masters degree in Statistics from the University of New South Wales and a Ph.D. in Statistics from North Carolina State University.
Statistical analysis software
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment