Services

Our consultants combine their pharmacovigilance expertise with information technology to continually stay on top of current global regulations, business issues and trends in the industry to, in turn, help companies meet their best practices for drug safety. We offer support for all stages of the software implementation lifecycle.

Readiness Assessment • A one-week readiness assessment to assist in understanding the technical, functional and regulatory implications of upgrading to the next version of your commercial safety system.

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

Custom Reporting • Design and development of custom and company-specific reports to augment the out-of-the-box reports available in your cmmercial system.

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 your internal system(s).

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.