(WINTER 2010)

An elective course in the Certificate Program in Clinical Trials: Medical Device and Drug Development.
Increase your expertise on the application of new technologies and redesigned processes to streamline clinical trials. Learn how to improve the efficiency of traditional clinical research cycle-paper-based processes utilizing information technology. Participants gain valuable knowledge of electronic processes used to plan, collect (acquire), access, exchange and achieve data required for conduct, management, analysis and reporting of clinical trials. Increased information accessibility and flow will allow the faster conduct of clinical trials with higher built-in quality. Ultimately, this will lead to higher degrees of safety and well being of patients. Prerequisite: BIOSCI X450, Fundamentals of Clinical Trials, MED X413.43, Clinical Data Management, or equivalent experience. See enrollment confirmation for login information. See enrollment confirmation for login information.

Sinisa Petkov, B.A., manager of clinical systems development, Allergan, Inc., has sixteen years of experience working with various electronic systems used for processing clinical trial data at pharmaceutical and medical device companies. He is involved with all aspects of the clinical systems development lifecycle including clinical system evaluation, selection, implementation and management. In addition, he has been involved in the development of a range of solutions from the early CANDAs (Computer Aided NDAs) to current eClinical solutions.