Application Components and the Integration Impact on a MedDRA project Implementation Plan dsNavigator & DXS (Data eXchange Service)

dsNavigator Overview

dsNavigator TM 3.0 Overview Premier coding solution Superior: –Navigation and Browsing –Coding Workflow Management and Auto encoding –Dictionary Management –System Administration Utilized by 80% of the top 10 global pharmaceutical companies Available in ASP and enterprise (client hosted) versions Fully compatible with leading safety systems Powerful functionality in a user-friendly environment that is customizable to your workflow

dsNavigator 3.0 Key Features Encoding Functionality: –Advanced auto encoding algorithm utilizing scoring system –Provide suggested best matches (1 best match, top 5, 10, etc.) Dictionary Flexibility: –Support for multiple, simultaneous dictionaries, including custom dictionaries –Advanced sub-searching capabilities –Integration package allowing for multiple coding workflow scenarios –Can assign term attributes for any dictionary Semantic Control Flexibility: –Fully customizable coding algorithm (support for multiple algorithms) –Ability to create and manage multiple synonym lists Performance: –Unlimited auto encoding run: auto encoding of tens of thousands of terms at one time –Response times: search for a term in seconds –Available simultaneously worldwide Integration: –Seamless integration with safety and clinical databases (homegrown and off-the-shelf)

Components: System Architecture