With Flex Databases Pharmacovigilance, you’ll only need one case, and you can add as many languages to it as you want.
Flex Databases Pharmacovigilance is a comprehensive drug safety database that ensures robust and compliant pharmacovigilance activities both within clinical trials and post-approval stage. End-to-end process of collecting, triage, evaluation and submission of safety data in a single point.
- Create or align your own pharmacovigilance process with the system by utilizing the embedded, fully configurable workflow
- Communicate with partners and regulatory authorities directly via EDI gateways
- Make reports in any format, required by regulatory authorities
Data-informed decisions on a drug safety profile
- We leverage the latest technologies for advanced safety data analysis and evaluation
- Our reporting tool kit is designed to provide instant data accessibility for further interpretation and actions
- Qualitative and quantitative (statistical, machine learning, neural network) methods for signal detection and management
- Multi-language input
- Configurable workflows
- Multi-tenant access
- 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
- PSUR/PBRER/DSUR line listings
- Summary tabulations builder
- Report calendar to manage periodic reports timelines
Paper-based and electronic reports
- CIOMS I
- MedWatch 3500A
- E2B R3 compliant XML report
- Local reporting forms on-demand
- Follow up report management
- Signal detection and management using qualitative and quantitative (statistical, machine learning, neuralnetwork) methods
- Ad-hoc reporting tool
- Duplicate search
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
- Submission tracker with country-specific setup of reporting timelines
- Notifications / alerts on actions to be taken and upcoming deadlines
What sets Flex Databases apart
We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient 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.
What they say about us
eTMF (electronic Trial Master File)
Project Management & Budgeting
LMS & QMS
CTMS (Clinical Trial Management System)
Have we picked your interest?
Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.