DMS (Document Management System)

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

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.

More about DMS

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.

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RWE-ready eTMF for 24/7 transparency in your documents

To make everyone’s lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of default templates. 

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SOLTI academic research group gets full transparency of clinical operations with Flex Databases CTMS and eTMF implementation

With Flex Databases CTMS & eTMF implementation, SOLTI aims to perform detailed analysis based on the information included in the system, have an operational data repository easy to consult and to easily extract reports of transversal data for company statistics and performance over the years.

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5 examples of data sets that are shared between Flex Databases CTMS & eTMF

Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible level of data completion and avoid missing documents issues.

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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.