Oracle Clinicals® Advantages & Setup

» Advantages
» Features



• Fully integrated for global data management
 • RDE enabled for entry from anywhere in the world
 • High level security features
 • Incorruptible database setup
 • Complete audit trail mechanism, ready for data audit by regulatory
• Possible enablement to global lab data capturing
 • Data export to SASŪ
 • 21CFR Part 11 compliant
 • Disaster recovery mechanism through backup at ACT-US

Oracle Clinical Setup @ACT

Features Top

• Integrated subsystems for

   - Study design
   - Study data definition
   - Study conduct
   - Analysis and reporting
   - Laboratory reference ranges

• Powerful built-in discrepancy management system providing total management of each    discrepancy   from creation through to resolution
• Full audit trails on data definitions, patient data, and discrepancies
• Flexible Batch Data Load
• Integrated randomization
• Create any number of data snapshots for interim analysis during normal data processing
• Query the data through an online query facility
• Include locked or frozen data, as well as discrepancy status information, in extracted data.
• Develop detailed visit schedule specification and tracking, including the identification of  missing and late   Case Report Forms (CRFs).
• Manage and track treatment blind breaks.
• Track patient availability and withdrawal information.
• Total Security to the database is ensured from external access/corruption with a robust    firewall.
• Highly secured data management premises with fully controlled Proximity Access System.
• Reliable backup and restore policy that keeps the data safe. It reduces the time required    to back up and   recover mission-critical data.

Compliance of capabilities include management of user accounts, configurable security, automatic recording of audit trails for both patient data and metadata, preservation of data during system upgrades, electronic signatures etc.