Periodic TMF reviews automatically documented. Quality and completeness under control!
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
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.
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.
- 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
- 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
- Fully validated, all related documentation is provided
- 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
- 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
- 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
- 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
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.
Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.
Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.
What they say about us
CTMS (Clinical Trial Management System)
eTMF (electronic Trial Master File)
Project Management & Budgeting
LMS & QMS
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.