Flexible eTMF & eISF Management Solution

Affordable and easy to implement

An affordable and intuitive eTMF/eISF document management solution. Cognidox helps you digitise paperwork and processes, making it easier for clinical trial units to 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.

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.

Alaric Taylor, Co founder at Vesynta

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

Explore the eQMS platform features

Lean eQMS

A Quality Management System right-sized for your needs

Document Management

Digitise your document control

Design Controls

Phase gate and document your entire design process

Business Management System

Ensure oversight and control with graphical business management

Extranet & Collaboration

Fast and secure information management

CAPAs & Non-conformance

Detect, correct, and prevent quality failures

Supplier Management

Monitor and manage supply chain quality

Learning Management

Tracking and self-attestation made simple

Change Management

Change control when it matters most

See Cognidox in action

Book a no obligation live 60-minute demo and discover if Cognidox is the right fit for your business.

Some of the most frequently asked questions

eTMF (electronic Trial Master File) & eISF (electronic Investigator Site File)

Do you support the TMF Reference Model (and our own variants)?

Yes. Start from TMF RM or your sponsor/CRO model. You can clone a full TMF/eISF structure for each new study with a few clicks—preloading folders, naming, draft templates, and workflows.

How is access controlled for sponsors, CROs, and sites?

Granular, role-based permissions: a site can log in and only see its own eISF, while sponsor/CRO users see the appropriate eTMF zones.

What do we gain over SharePoint or paper?

Rock-solid version control, Part 11-compliant e-signatures, immutable audit trails, and configurable workflows. You get a single source of truth, not a pile of folders.

Can sites submit documents (or forms) directly?

Yes. Use guided request-to-upload with metadata rules to land files in the right place and route them for QC. Secure form capture can be used for structured data collection where appropriate.

How are changes, sign-offs and history handled?

Each edit/save creates a dated draft linked to the user; approvals use role-based e-signatures at closure. Full history shows who did what, when, and why.

Is it GxP-ready and does it connect to our QMS?

Cognidox is built for GxP use with validation support (CSV/CSA), and it ties into your wider quality modules (e.g., CAPA, Change, Training) so TMF gaps can trigger actions and training—closing the loop.

Can I archive a trial in Cognidox once it’s completed?

Yes. Create a dedicated trial archive area and move the study artefacts into it, then lock down access by role so only authorised users (e.g., QA, records team, auditors) can see archived content. Archive moves preserve version history, audit logs and retention/expiry settings, and items can be restored or exported if required — so you get a secure, auditable record of the closed study without cluttering the active eTMF.

Can I hold both internal and external training records?

Yes, training is group based in Cognidox offering read & understand, quizzes, evidence submissions, feedback loops and/or assessment options where levels of competence are required.