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SMARTVIGILIT
Smart literature surveillance
SMARTVIGILIT® system is a quality-assured environment that supports all functions related to your legal obligations for literature surveillance. The service has been successfully inspected by MHRA and BfArM. It independently performs weekly database searches within PubMed. It is a web-based solution that can be accessed by any browser / operating system worldwide. You can assign as many users as needed.
After setting up searches in consultation with the client in the SMARTVIGILIT system, we continuously monitor the safety literature for the relevant product. A team of well-trained and experienced staff will be responsible for the references rating within the system. Alerts on potential cases will be identified and made available to you via an automatic push mail. Process detected case reports can also be automatically pushed to you in a CIOMS I or E2B-compatible format, if needed. A duplicate check is performed for all your case reports against cases provided by the monitoring of medical literature service from EMA (MLM). Other safety literature relevant for your products can be queried by category, product name and time interval without additional fees to perform e.g. signaling or create PSURs. SMARTVIGILIT can be integrated in your current pharmacovigilance system.
Features
- Global coverage for all substances
- No user limitations
- Comprehensive, e-enabled, easy to access platform
- Validated solution in line with GAMP 5, compliant with US Title 21 CFR part 11
- Web-based tool, no install / update required for customers, easily scalable
- Fully integrated in PV services (end-to-end processing)
- Classification of ICSRs, PSUR relevant, efficacy information
- Profound expertise paired with consulting activities
- Automatic import of literature references from various databases (e.g. PubMed)
- Triage and assessment of references
- SafeGuard AI to identify potentially overseen ICSRs
- User frontend, generation of reports
- Automated push-mail to client with identified references for different categories
Benefits
- End-to-end solution: integrated part of our service landscape, our tool covers the steps of PV literature screening from import, assessment to full case processing in standard formats (e.g. E2B XML, CIOMS, MedWatch)
- Improved compliance: service successfully audited / inspected (MHRA recommendation); quality level (GAMP-5); Title 21 CFR Part 11/Annex 11 compliant
- Gain efficiency: detection of duplicates from and streamlined processing of safety relevant literature references for ICSRs, periodic reports, efficacy evaluation
