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
Dashboard
Case management
Audit trail

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
Report Creation
Query Management
Submission Status

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

Periodic submissions

  • 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

Advanced analytics

  • 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

Reporting Timelines

  • Submission tracker with country-specific setup of reporting timelines
  • Notifications / alerts on actions to be taken and upcoming deadlines

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 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.

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.

What they say about us

John Douglas Snowden
Senior Vice President of Technology Innovation at NCGS, Inc.
NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.
Tameo Kobayashi
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
Joshua Baisley, H.B.Sc.
VP, Clinical Design and Delivery
As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

More about Pharmacovigilance

Flex Databases recognised as one of top-10 Pharmacovigilance providers in the UK & Europe

This September, Pharma Tech Outlook included Flex Databases in Top-10 Pharmacovigilance solutions providers in the UK & Europe.

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Video: The way we save time on case intake in Flex Databases Pharmacovigilance module

In this video we talk about the way Flex Databases Pharmacovigilance module helps to save time on case intake.

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Answering 6 most frequently asked questions about Flex Databases Pharmacovigilance module

lients. That’s why to save your time and give you a deeper understanding of how our Pharmacovigilance module work, we are happy to answer the six most frequently asked questions about the system.

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Synchronizing safety data from EDC/eCRF with Flex Databases Pharmacovigilance

Flex Databases is ready to arrange the automated data flow from any eCRF/EDC used by Sponsor or CRO to our Pharmacovigilance module.

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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.