Paper Trials Data Management

•  Validated, CFR-21 Part-11 Compliant Data Entry System

•  SAS Database Design and Detailed Data Management Plan

•  Validated Double Data Entry

•  Medication/AE Coding

•  Computerized Edit Checking

•  Integrated Electronic Query Database and Tracking

•  Electronic Audit Trail

•  CRF Tracking

•  Custom Data Management Reports