eTMF – a clinical investigation documentation system

Our user-friendly, cost-effective, and regulatory compliant eTMF system helps in making your clinical studies easier.


It’s time to update your clinical investigation system to an efficient and regulatory compliant eTMF (electronic trial master file) solution. Have it tailor-made exactly the way you want it, whether you choose to work locally or internationally. In the process of performing clinical studies, a thorough update will give you an all-in-one system for easier usage and efficiency. Add to that an electronic investigator site file (eISF) complete with an active system support.

Key2Compliance® offers a user-friendly, cost-effective, and regulatory compliant eTMF system. Our solution uses Focalcube, a powerful platform with an eTMF structure aligned with ISO14155:2020 requirements, keeping your studies regulatory compliant while being easier to operate.

Key2Compliance® aids you in:

• Regulatory compliance – our solution is ISO14155 compliant for all essential documents collected during clinical studies.

• Creating your own documents, or sending and emailing your documents to the Focalcube inbox.

• Active personal support to attend to any queries and concerns you may have with the system.

• Environment-friendly – will reduce your ecological footprint by an online eTMF.

• Final checking and documentation to ensure a complete eTMF.

Optional features:

• Electronic signature.

• Direct mailbox into eTMF.

• Digital or final archiving solutions such as a USB flash drive or a zip-file.

A user-friendly, all-in-one solution for your needs

By using Focalcube, Key2Compliance® can offer a complete, easy-to-use, eTMF system for your company. We’ll help you tailor the folder structure in accordance with ISO 14155:2020 and set everything up for you.
With our active support available via e-mail, phone and Teams chat and our friendly team is happy to promptly attend to your questions and queries about the system.

Locate and manage your documents with ease

Through the separate document collection option, you can quickly and easily locate specific documents and keep them separate. Focalcube allows you to create new documents within the system while also tracking the full revision history.

Focalcube is fully integrated with Assently, which allow you to legally send and sign documents electronically within the system, both as an internal and external user.

A powerful and flexible cloud-based eTMF solution built for you

The eTMF solution of Key2Compliance® aids MedTech companies to start up a new clinical study or update an old, paper-based system in order to build a more active, shareable, and effective document handling system. With our cost-effective system, you can choose to work locally, internationally, or in any way that suits your needs. Additionally we’ll help you build your eTMF and electronic investigator site file (eISF) according to ISO14155:2020 or ICH-GCP (R2) with active support whenever needed.

By switching to a digital, cloud-based system allows you to work more efficiently. With Focalcube, you gain full control regardless of where you are working from so that audits and inspections can be successfully carried out remotely.

The quality required for a modern and efficient life science company will undoubtedly be met and maintained. Your staff will have full access to the entire eTMF, including all cases and other documentation, while limited access can be granted to external users.

Interested in upgrading your documentation system? Contact us

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