Safety Database Consulting

What Pharmaceutical Firms Look For

Safety system implementation for processing and reporting expedited reports to Health Authorities
A fast and effective implementation with low maintenance
Argus Upgrade assistance
Vendor Oversight and Maintenance
Assist with Safety Migration during acquisitions
RFP Process
Technology Consulting

Code List Configuration
Business Configuration: Products and Licenses, Study and Reporting Rules configuration
User Access Management: Argus and LAM user accounts setup
System Configuration: Case Priority, Field Validations, Common Profile Switches, Reporting Configuration, Workflow Setup, User-Defined fields
Argus Upgrade Impact Assessment on existing data entry conventions and re-defining the new process
Argus Upgrade Impact Assessment on the existing custom reports
Bridge the gap between Pharmaceutical client and safety vendor, translating the business requirements to technical requirements
Handling the System changes as safety owners and ensuring the changes have been made as per the client's SOPs and standards
Define Data Transfer Strategy, Business Mapping Requirement authoring and analysis for Safety Migration between source and target systems during Acquisitions
Assist with RFP process authoring for implementing new safety systems and Signal Management tools implementation
Compare and suggest technologies/vendor and tools selection for client needs - Safety systems, Reporting tools, Signaling Tool