Trial Master File: paper vs eTMF
March 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:
| 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.
Learn more about Flex Databases eTMF or request a free demo: bd@flexdatabases.com.
