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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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compliant with FDA
ISO 27001_2022

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

Data structure

Dashboard

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

Template Configuration

My Views

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

Drug Development

Data Structure

Data Structure

Messages

Messages

Features

Dashboard
  • 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
Data structure
  • 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
Drug Development
  • 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
Template Configuration
  • 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
My Views
  • 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
Messages
  • Custom metadata setup and management
  • Various metadata structures templates
  • Metadata actions (e.g. notification on expiry date of the document)
  • Dynamic metadata reports

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.

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.

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.

Maya Bhattacharya

Manager, Global Regulatory Affairs Operations

We knew Flex Databases was a game changer, providing confidence to what we could do next within the Clinical space, considering our trials/patients. SPARC choose Flex Databases due to system flexibility and checking the boxes for ALL of our major requirements. We also wanted the latest and greatest technology considering the long-term advantages of having one solution with the increased possibilities of integration.

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

More about DMS

Anything you can do, with DMS would be better – manager & user perspective
September 6, 2023
Anything you can do, with DMS would be better – manager & user perspective

Document management & storage is rarely considered as something complicated, however, it’s a backbone for everything. When it’s done wrong, you’ll experience process delays, incomplete or missing documents, and other data integrity & completeness issues. Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get […]

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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.