DMS (Document Management System)

Manage all your documents in a smart way – have them organized, easily accessible, and ready to use.

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A comprehensive system designed to enhance efficiency and compliance throughout your document lifecycle

eSignatures as an in-built part of the system: ensure e-signatures that comply with all legal requirements. With a clear indication of signatory identity, signature reason, and timestamp, you can confidently rely on the authenticity of your documents
Fully validated for regulatory compliance: our system adheres to the highest standards. It is developed in alignment with 21 CFR Part 11, ensuring data integrity and security in FDA- and EMA-regulated environments
Seamless integration for data reusability: unlock the true potential of your information. Our Document Management System (DMS) seamlessly connects with other systems, facilitating easy data exchange and reusability for future needs

Data structure

Dashboard

Have a user-friendly system that can be navigated intuitively without excessive training

Effortless communication options: infinite communication tools at your fingertips. Leave comments directly on the documents, initiate chats with team members, and raise queries.
Full document tracking and archiving: keep a complete trail of all document actions and changes. Our system ensures comprehensive tracking, enabling easy extraction of data when needed. Additionally, utilize our archiving function for organized data storage and retrieval.
Smart search and filtering: find what you need in seconds. Our powerful search function allows you to locate specific documents with ease. You can also filter documents by status, milestone, completeness, and more, enabling efficient organization and access.
Send in and out: use any of your favorite ways to upload a document into the system – drag and drop, upload it from your computer, or even send a document into the system. And it goes both ways: email your documents directly from the system.

Template Configuration

My Views

A ready-to-use system with extreme flexibility

Tailored access control: effortlessly manage user permissions by differentiating access levels for team members, external auditors, or inspectors based on your preferences and security needs.
Choose from built-in or customize your structure templates: our system offers a wide range of pre-designed templates to suit various project structures. Alternatively, you can create your own templates, ensuring that your data is organized in a way that aligns perfectly with your workflow.
Create your own workflow: empower your organization with a fully customizable workflow. Design and implement workflows that mirror your specific processes, streamlining document management and ensuring efficiency at every step.

Drug Development

Data Structure

Messages

Features

General settings

Simple DMS template creation and configuration
E-mail blasts from DMS to sites
OCR – system recognizes text in pictures, scans, photos
Online viewing and authoring via browser without download
Email alerts
Flexible access matrix

Web-based: no installation needed
The system can be hosted both cloud-based and on-premise
Single sign-on functionality is available using LDAP and SAML protocols
API is available for use in bidirectional integrations
System recognizes special/foreign characters

Compliance

21 CFR Part 11 compliant
Access control, based on project role, sites, folders, countries and for external users
Full Audit Trail and versioning

Easy archiving of DMS projects with index and audit trail
GDPR-compliant
Fully validated, all related documentation is provided

Upload

Automated filing of documents from CTMS
Email upload – send email with attachment directly to DMS
Batch documents upload and download

Drag and drop function
DMS connected as an external drive through WebDAV protocol
Mobile application

Quality control

Adjustable notifications and alerts
My Views section – user-defined lists of documents based on metadata groups
QC Workflow for all file types, folders and placeholders

Chat and comments available for documents and folders
Documents review, approve, lock, sign configurable workflow and electronic signature

Reports

Real-time statistics on folders completeness
Business Intelligence: widgets and reports

Ad-hoc reporting tool for cross-project & cross-module reporting
Powerful search engine by various parameters in name and file content

Metadata

Custom metadata setup and management
Various metadata structures templates

Metadata actions (e.g. notification on expiry date of the document)
Dynamic metadata reports

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.

Apr 10, 2024

Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF […]

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Feb 22, 2024

How we implemented eTMF & developed SOPs in 3 weeks for iRenix

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.

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Jan 25, 2024

TMF Quality Review 2.0

Periodic TMF reviews automatically documented. Quality and completeness under control!

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Jan 18, 2024

Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases

Flex Databases offers a solution for all your archiving needs.

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Get in touch to discuss compliance, implementation, demos, pricing

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.

DMS (Document Management System)

A comprehensive system designed to enhance efficiency and compliance throughout your document lifecycle

Have a user-friendly system that can be navigated intuitively without excessive training

A ready-to-use system with extreme flexibility