Trial Master File Management for Clinical Research

Document management
Workflows
GxP compliant
e-Signature approvals

Read Our Case Study

Electronic Trial Master File Document Management

Introducing an affordable and intuitive eTMF/eISF (Electronic Investigator Site File) document management solution. Cognidox helps you digitise paperwork and processes, making it easier for clinical trial units to efficiently manage documentation and ensure audit readiness across multiple trials.

NCCPG Case Study: Stress-free clinical trial document management with Cognidox

The digital tools you need to become a world class clinical trials unit

Cognidox gives clinical trial units and university research teams an intuitive, budget-friendly way to stay compliant - without the cost and complexity of enterprise solutions.

✔ Always audit Ready: Secure, GxP-compliant document control with built-in eSignatures and audit trails.
✔ No IT required: Easy setup, user-friendly interface, and no costly system integrations.
✔ Organised & accessible: A logically structured filing system for fast document discovery and retrieval.
✔ Faster approvals: Automated workflows and notifications keep trials moving.
✔ Cost-effective compliance: Get the core eTMF functionality you need - without paying for unnecessary extras.

Ditch paper files, shared drives, and overpriced software. With Cognidox, clinical trial documentation stays structured, secure, and always ready for inspection.

Clinical Trial Document Management Software

Supporting you to conduct data rich clinical trials

Cognidox keeps critical trial documentation organised, accessible, and inspection-ready—without the IT headaches.

✔ Supports research innovation: Simplifies document management, freeing up time for critical research tasks.
✔ Enables collaboration: Facilitates seamless communication between site teams, improving efficiency.
✔ Promotes regulatory readiness: Keeps site-specific records structured, secure, and easily accessible during inspections.
✔ Improves data integrity: Ensures accuracy and transparency with automatic audit trails and version control.
✔ Boosts operational efficiency: Reduces administrative burden, allowing teams to focus on research outcomes.

Cognidox helps research-driven environments streamline their document management, enhance collaboration, and ensure compliance; all while freeing up resource to deliver more, data-rich clinical trials in the future.

Read our case study on Good Clinical Practice Guidelines

Standard features

Document control

Workflow automation

Training tools

Software validation

Compliant e-signatures

Quality modules

A Guide to GxP

From GDocP to GMP: ensuring data integrity and process control for FDA, EMA, and ISO compliance

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See what our customer say!

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Cognidox is by far the easiest eDMS/eQMS to use and scores with a full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file-type and does not use thrid-party "logic", such as MFiles or alike.

Guenter Duerr, Director at Capsero

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and is saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

The system is flexible and can easily be customised to your organisational needs. The price point makes it an option for small companies that could benefit from an eQMS but do not have the funds to go with the more popular packages.

Linda Garrod, Quality Consultant at Ivdeology

The search facility sits at the top of the interface at all times and is extremely powerful and quick, and the advanced search facility is excellent.

David Ahern, CEO at Coalesce Product Development

Cognidox is easy to use and simplifies processes! The support and training provided are fantastic.

Julie Errington, Clinical Trials Manager at NCCPG

Cognidox is a very versatile software, pre-configured for many different Quality Management Systems and yet very easy to use and configure.

Fabio, CEO

The entire process from demo, training and implementation has been wonderful. The acceptance of the tool within the organization was very fast and growing by the week! This is a very versatile product and is simple to use. The workflows are very powerful and helps build compliance to several standards with ease.

Prasanna, COO

We trust Cognidox - it is robust, and with a careful setup, it is almost impossible for us to break it inadvertently. Importantly, this helps focus us on value (document content) and less on administrative process. In contrast to some consultants, it is always available, has excellent value, scales with the team and is easy to manage.