Readiness Assessment • A one-week readiness assessment to assist in understanding the technical, functional and regulatory implications of moving to Oracle® AERS version 4.5.2/4.6.

Implementation & Upgrade • Comprehensive support for initial implementation or upgrade of Oracle AERS to meet business goals and to comply with worldwide regulatory guidelines.

Custom Reporting • Design and development of custom and company-specific reports against the Oracle AERS data model and other related systems.

Continuity Planning & Data Archival • Development and execution of a business continuity plan to ensure 24/7 access to all clinical, safety and related data.

Compliance • Development and implementation of systems and business processes to ensure compliance with worldwide government regulations.

Software Evaluation & Selection • Direction of the software evaluation process from proposal writing through selection to ensure that candidate systems meet financial, technical and safety requirements.

Data Migration • Planning, executing and testing the migration of legacy data and data from other commercial safety systems into Oracle AERS.

Project Oversight • Assistance with medium and long-term project design and implementation to ensure clear and valid objectives and requirements and effective planning and management.