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.

Product Sheet PDF

ISO 9001-2015 label certification new version

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

Product Sheet PDF

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

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

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

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 They Say About Us

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.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Have questions?

Drop us a line and we be happy to answer all your questions

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

CTMS Blog

August 25, 2026

How Flex Databases’ Review and Merge Tool Transforms Pharmacovigilance Case Processing

Every pharmacovigilance case tells an evolving story. A case rarely arrives once and stays static – new information keeps surfacing after the initial intake: a patient is hospitalized, a birth date gets corrected, a new reaction is reported, a concomitant medication comes to light. For safety teams processing cases from clinical trials, marketed-drug consumer reports, […]

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July 15, 2026

How ITS Cut Manual Safety Tracking by 60% and Strengthened PV Oversight Across Clinical Trials

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]

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September 30, 2025

Subject Tracking & Invoicing – Data Import Wizard.

Cross-site budget setup can turn into hours of manual per-subject cost entry, slowing teams down and creating error risks. With Flex Databases’ Subject Tracking & Invoicing, you can now import Per Subject Costs directly from Excel using the Data Import Wizard. ✔ Speed up site budget setup✔ Reduce manual entry and errors✔ Import across projects […]

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August 14, 2025

Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were […]

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We are here for all of your questions! 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.