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Home / News & Events / Clinical PK Graphical and Tabular Reporting using S-PLUS

Clinical PK Graphical and Tabular Reporting using S-PLUS

Presented: Tuesday, October 24, 2006

Speaker: Michael O’Connell & Joel Hoffman, Insightful Corporation

Listen to the archived web cast.

Download the web cast presentation.

When clinicians and pharmacologists perform toxicology and pharmacokinetic studies during early-phase clinical trials, they need to assemble their results into clinical study reports to share with colleagues and regulatory agencies. In many current situations, clinicians, pharmacologists and statisticians use manual report preparation and QC methods. This is an inefficient use of valuable time that highly talented scientists could be spending to interpret, plan and execute trials for development of new chemical entities.

In contrast, automated processes and software that create standardized clinical study reports saves time, standardizes best practices, removes manual errors and allows high-value professionals to spend their time advancing the drug development process. Such standardized reports enhance understanding and comparison of results and enable rapid and accurate presentation of results to the FDA, and to colleagues within companies and the scientific community at-large. At the same time, the implementation of the right software can enable reporting that is sufficiently adaptive and flexible to meet the evolving requirements of early-phase clinical studies.


Michael O'Connell,
Insightful Corporation

 Michael O'Connell has been working in the medical device, diagnostics, pharmaceutical and biotech arena for the past 15 years. Dr. O'Connell's background and graduate work was in applied statistics and he has published more than 40 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 using S-PLUS, R and SAS. Most recently he has been active in bioinformatics and the statistical analysis of microarray data; and in the development of tools for analysis and reporting of clinical and safety data from S-PLUS.

Dr. O'Connell 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.
Joel Hoffman,
Insightful Corporation		 Joel Hoffman, PhD, is an expert in biopharmaceutical development systems and standards and has more than 25 years experience in life sciences: academic (Harvard Medical School / Harvard School of Public Health), pharmaceutical industry (Pfizer), and consulting companies. At Pfizer, Joel developed systems for electronic submissions, electronic data capture, the analysis and reporting of clinical data, and a clinical data warehouse. As a consultant, Joel developed operational systems and systems for the analysis and reporting of PK data. As Director of Life Sciences for Insightful Corporation, Joel is working with colleagues to focus on Insightful's research, development and experience on products and solutions that will further enable life science enterprises to deliver medicines to patients who need them.