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:
Paper TMF
eTMF
Limited physical access, no possibility for remote access
Safe instant access from anywhere in the world
Limited search abilities due to the huge amount of physical papers
Powerful search engine: find any document in one click
No progress tracking is available within the paper documents, additional efforts are required
Real-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 required
Full Audit trail tracks all actions within the system: Who, What, When, Where, and Why
Countless working hours required to prepare paper files for an audit
Automated 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 damage
Cloud-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 dates
eTMF 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” feature
Customizable widgets and reports assure trial transparency and provide information for data-driven decisions
Flex Databases offers migration from paper to digital in 5 weeks.
Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts
Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF […]
How we implemented eTMF & developed SOPs in 3 weeks for iRenix
And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.
Get in touch to discuss compliance, implementation, demos, pricing
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