Signal detection – the complete guide
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SMARTVIGILIT
Smart literature surveillance
SMARTVIGILIT® is a web-based solution with a quality-assured environment that accomplishes all the functions related to your legal obligations for global and local literature surveillance. It independently performs weekly automated searches within PubMed or other databases. Also, safety-relevant medical and scientific literature for your products can be extracted from system by product name and time period to support all your pharmacovigilance processes at any given point in time. e.g., signal detection and PSUR(s) / PBRER(s) preparation and eventually benefit-risk evaluation (BRE) of medicinal products.
Features
- Global coverage, end-to-end service for all your substances.
- Web-based access, no install / update required for customers, easily scalable.
- No user license limitations. You can assign as many users as needed.
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Management of literature references from global and local literature databases with individual designed search strategies.
- Artificial Intelligence (AI) enabled system for quality review.
- Automated email notification services for:
- Identified literature abstract(s) with different technical segregation.
- Case reports (ICSRs) in CIOMS I or E2B-compatible (R2 & R3) format.
- Competent integration with all Pharmacovigilance setup(s).
Benefits
- Successfully inspected by MHRA and BfArM.
- A validated solution in line with GAMP 5, compliant with US Title 21 CFR part 11.
- One-stop solution for the entire literature aspect of PV-related activities.
- Profound pharmacovigilance expertise paired with consulting activities.
- Drastically reduces the effort required in eliminating duplicate references as well as the load on the screening.
- Export of segregated references in the required format (PDF and CSV) with adequate information.
