Validated and Maintained Argus Safety.
Improved Data Consistency and Accuracy.
Applying best practices to address your business challenges, we expertly configure the Argus Safety database to meet your needs. Fully validated and 21 CFR Part 11/Annex 11-compliant, your customized pharmacovigilance database is scalable to grow as your business grows.
We build iterative, intuitive workflows and reporting for your pre- and post-marketing activities to help you make faster, more informed pharmacovigilance safety decisions. In addition, we provide complete regulatory inspection support — on site if necessary.
You’ll achieve improved efficiency with features such as:
- Custom auto-population of case narratives, letter generation and information requests to ensure data consistency and reduce error
- Case prioritization rules to identify critical cases
- Custom E2B profile mapping, gateway architecture and edit checks to align with regulatory requirements
- Global expedited reporting rules to eliminate manual effort
- 21 CFR Part 11/Annex 11-compliant change control, including automated functional requirement specification (FRS) refresh
- Regulatory inspection support and system validation defense
- Dedicated help desk with rapid response and troubleshooting from staff with technical and operational (drug safety) experience