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.
| 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.
With Flex Databases CTMS & eTMF implementation, SOLTI aims to perform detailed analysis based on the information included in the system, have an operational data repository easy to consult and to easily extract reports of transversal data for company statistics and performance over the years.
Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible level of data completion and avoid missing documents issues.
We asked CEO André Warnke a couple of questions about the upcoming partnership
iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
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.