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February 10, 2010

EmpiriStat to Present at 2010 SCT Annual Meeting

EmpiriStat, Inc. professionals have been recognized by their peers to conduct workshops at the 31st Annual Meeting for the Society for Clinic Trials and to present during the Annual Meeting. Dr. Nicole Close, Mr. Doug Domalik and Mr. Devin Hunt will be among the presenters.

The SCT Meeting is a combination of Invited Sessions and Contributed Sessions. The programs are a diverse, timely and informative collection of topics featuring a multi-national faculty.
Created in 1978, SCT is an international organization dedicated to the development and dissemination of knowledge about the design, conduct, and analysis of government and industry-sponsored clinical trials and related health care research methodologies.  Dr. Nicole C. Close, EmpiriStat President and Principal Biostatistician, related that “SCT is a very important organization that I will be dedicating a considerable amount of time to in my role on the Board of Directors. It is not just because I was elected to do this, but I truly believe in the Society, the collaborations it develops and the educational aspects it brings to both Junior and Senior level colleagues.”
On her attempt at taking the ‘dry’ out of biostatistics, Dr. Close says that “When people ask me what I do and I say proudly that I am a Biostatistician, a look of disbelief predictably comes across their face followed by a comment that they never did well in the Statistics class that they had. The goal in any of my workshops is for people to leave with a good feeling about statistics, that they actually understood the concepts and that the course was engaging and energizing. They don’t leave the course as a Statistician, but they do leave with a new understanding and appreciation of the concepts, and maybe, just maybe, I have changed their reactions to a Biostatistician.”
Dr. Close will present “I am NOT a Statistician, But I Understand What You Are Saying.” This workshop, designed as an introduction to the statistical principles which form the foundation for the design and analysis of clinical trials, concentrates on the philosophy and understanding of the statistical principles that are used on a day-to-day basis in conducting clinical trials. The subject of Statistics can scare some people, but don’t be scared. Dr. Close intends this course to be valuable to all members of the clinical trial team and will NOT simply present statistical principles and formulas as a math lecture. EmpiriStat is a vibrant and effective departure from the typical Contract Research Organizations and Dr. Close believes that learning and understanding the importance of statistics in clinical trials can be just as vibrant. 
In his “Essentials of Clinical Data Management” workshop, EmpiriStat’s Manager of Statistical Programming, Devin J. Hunt will provide real-world experience to familiarize participants with the specific tasks involved in clinical data management. Taught from the perspective of a Data Manager and Database Programmer, participants will examine the steps, processes, regulatory requirements and best practices for clinical data management. This course applies to personnel entering into the clinical data management field, personnel needing a refresher course, or personnel who interact with data managers and need to understand data management’s responsibilities. This course would also benefit anyone who is involved in the planning and preparing of a clinical trial, conducting a clinical trial, or has management responsibility (direct or indirect) for clinical trials.
An area of great importance in clinical trials is safety of the subjects participating. Mr. Doug Domalik, EmpiriStat’s Safety Director, has organized and will be presenting at an Invited Session during the Annual Meeting. This session focuses on the basics of Risk Management Plans and their use both here in the United States and in Europe. 
The SCT 31st Annual Meeting will be held at the Marriott Baltimore Waterfront, Baltimore, Maryland May 16 - 19, 2010 (
Anyone interested in joining SCT or to simply to find more information, is encouraged to review their website (
For more information on EmpiriStat or bringing EmpiriStat’s educational series to your company, please go to or contact EmpiriStat directly at:
EmpiriStat, Inc.
13694 Sam Hill Drive
Mount Airy, MD 21771
Tel: 866.935.STAT (7828)
Fax: 866.276.STAT (7828)

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