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