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Anna will be a part of the Virtual Meet the Exhibitors event.
Manage all pharmacovigilance processes in one place
Collect, triage out, evaluate, and submit safety data.
Create and align your pharmacovigilance process with the embedded, fully configurable workflow.
Communicate with partners and regulatory authorities directly via EDI gateways.
Make informed decisions on a drug safety profile
Access data instantly for further deep data analysis with a built-in reporting kit.
Use qualitative and quantitative (statistical, machine learning, neural network) methods for signal detection and management.
Create reports in any format, required by regulatory authorities.
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the client involvement and requirements
Complete data safety
We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world
Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required
Data export in Excel, Word, XML and PDF
In-built MedDRA coding tool with auto-coding option
Comprehensive Audit Trail
Cross-field validation to ensure E2B compliance
Query chat for communication
Paper-based and electronic reports
E2B R3 compliant XML report
Local reporting forms on-demand
Follow up reports management
PSUR/PBRER/DSUR line listings
Summary tabulations builder
Reports calendar to manage periodic reports timelines
Signal detection and management using qualitative and quantitative (statistical, machine learning, neuralnetwork) methods
Ad-hoc reporting tool
Data reconciliation with third-parties
Integration with EDC / Clinical databases
EDI Gateways with partners or competent authorities
API-based data export
E2B R3 XML import
Submissions tracker with country-specific setup of reporting timelines
Notifications / alerts on actions to be taken and upcoming deadlines