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Pharmacovigilance – your comprehensive drug safety database

Full-cycle pharmacovigilance. Absolute compliance with regulations. Advanced reporting.

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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.

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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.

See full list of features

What sets Flex Databases apart

Easy implementation

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

Full compliance

Flex Databases is compliant with all major international and local regulations such as ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end-users. No installation required

Features

General

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

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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