Product Overview
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.
Full-cycle pharmacovigilance
- 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
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
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
About the company
Our company was founded in 2011 and to this day remains privately owned by our working managers. Our HQ is in Prague, Czech Republic, with additional offices in Switzerland, the U.S., and Turkey. Our clients are based all over the globe. About half are CROs, and half are sponsors including pharma companies, biotech, medical devices, and academic research.
Now, you are probably wondering about security, compliance, and validation. We provide truly comprehensive service, taking care of system roll out, implementation, data hosting, backups, security, as well as validation and compliance. We are GCP, GMP, HIPAA, GDPR compliant, have participated in numerous audits, and experienced helping clients during inspections.
