CRAdvantage 1.0w

The Tracking, Management and Reporting Software for Clinical Monitors and Managers

Clinical Research Associate Advantage Version 1.0w is a management tool that assists clinical trial professionals in collecting, storing and analyzing the necessary information and data for clinical studies. CRAdvantage Version 1.0w is a Windows(TM) based single user system that allows monitors and study directors to assess and monitor the progress of clinical studies. The system permits the collection of data relative to the visit schedule of subjects, comments about subjects, adverse events, monitor visits and deviations from protocols. Once these data are collected, the system provides numerous reports to assist both the monitor and the study directors in evaluating the progress of the study and in maintaining a history of subjects and monitor visits. To facilitate the applicability of the system to a variety of clinical studies the system allows a study director to define: each protocol, the investigators performing the study and a variety of characteristics for expected subject visits along with the eligibility criteria for subjects.

The Features

1. Protocol Definitions that include clinical sites, eligibility criteria, study visits (by date, time or combination) and protocol change history.
2. Complete Subject Histories that include visit history, monitor visit review history, adverse events, eligibility, medical history, protocol deviations and monitor visit comments.
3. Monitor Visit Recording that includes visit checklists and visit comments.
4. Flexible monitor visit checklists .
5. Reporting by patient/subject , clinical site , protocol/study and protocol status.
6. Monitor review queries and responses .
7. System utilities that support data transfer and report management.

For additional information contact Kelli Schneider @ (970) 207-9798 or

E-mail address ptc@socencom.net