Trial Master File: paper vs eTMF

Mar 27, 2020

Electronic Trial Master File or eTMF is not a new thing on the market, yet there are still companies working with paper solutions.

Of course, every single eTMF provider now has a “Now it’s time to change to eTMF because it’s online” kind of article, but we at Flex Databases believe, that eTMF is more than just cloud storage.

Here’s a comparison of a standard TMF with Flex Databases eTMF:

Limited physical access, no possibility for remote accessSafe instant access from anywhere in the world
Limited search abilities due to the huge amount of physical papersPowerful search engine: find any document in one click
No progress tracking is available within the paper documents, additional efforts are requiredReal-time progress tracking: everyone is on the same page with what is done and what needs to be done
Limited activity tracking options available, additional efforts and resources are requiredFull Audit trail tracks all actions within the system: Who, What, When, Where, and Why
Countless working hours required to prepare paper files for an auditAutomated folders completeness statistics, missing documents reports, and various notifications ensure constant inspection readiness
Paper documents require a lot of expensive storage space and can be easily destroyed by any way of physical damageCloud-based applications reduce storage costs to a minimum. Data in a cloud is safe and also cannot be destroyed by a fire, flood or any other way of physical damage
Additional trackers are required to maintain the relevance of paper TMF, follow timelines for essential documents, and monitor expiry dateseTMF provides customizable metadata for any document, an ability to set up notifications on any metadata related events (such as expiry dates) and use metadata for various reports building
Paper TMF simply does not provide any functionality on top of the “being a document storage” featureCustomizable widgets and reports assure trial transparency and provide information for data-driven decisions

Flex Databases offers migration from paper to digital in 5 weeks.

Learn more about Flex Databases eTMF or request a free demo:

More about eTMF

TMF Quality Review 2.0 

Periodic TMF reviews automatically documented. Quality and completeness under control!

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Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases 

Flex Databases offers a solution for all your archiving needs.

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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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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.