Development of a Clinical Study Report

Venue: Philadelphia Marriott Downtown

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Oct 26, 2007
Report as Spam


Examine best practices for preparing integrated clinical study reports for pharmaceutical products. Discussion will focus on the structure and format of a clinical study report, with special attention given to the inclusion and presentation of study-specific information and data.
•Structure and format of an integrated clinical study report in accordance with ICH guidelines
•Investigational plan through statistical methodology
•Study population and protocol deviations
•Placement and presentation of study information and data in various report sections, including tables, appendices, and supporting documentation
•Safety and efficacy results
•pharmacokinetic and/or pharmacodynamic endpoints
•Acceptability of abbreviated study reports.