Pharmacovigilance
| 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
MEDICAL REVIEW
QUALITY
SUBMISSIONS
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
ANALYTICS
特征
- General
- Multi-language input
- Configurable workflows
- Multi-tenant access
- Data export in Excel, Word 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
- CIOMS I
- MedWatch 3500A
- E2B R3 compliant XML report
- Local reporting forms on-demand
- Follow up reports management
- Periodic submissions
- PSUR/PBRER/DSUR line listings
- Summary tabulations builder
- Reports calendar to manage periodic reports timelines
- Advanced analytics
- Signal detection and management using qualitative and quantitative (statistical, machine learning, neuralnetwork) methods
- Ad-hoc reporting tool
- Duplicates 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
- Reporting Timelines
- Submissions tracker with country-specific setup of reporting timelines
- Notifications / alerts on actions to be taken and upcoming deadlines
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ImplementationWe can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Clients involvement and the complexity of the Client’s requirements. -
PrivacyFlex Databases protects customers’ data, ensures following the security regulations, and mitigates all potential risks which are essential to building trust and delivering the high-level of service. -
SecurityFlex Databases takes a risk-based approach to security, and this page details the measures and technologies implemented to protect our customers. -
ComplianceFlex Databases System is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
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Software solutions for CRO and Pharmaceuticals
We offer both single modules and a unified solution to maintain all processes - you can cover all existing software needs with only one vendor.
All modules developed by Flex Databases are validated and compliant with
21 CFR Part 11 and other regulations.