When we ask our clients why they’ve decided to implement one or another system, among many reasons, we always have something budget-related – it might be financial transparency, cost-effectiveness, and other variations.
Financial transparency is a big subject that we will cover soon in a separate article, but today is for cost-effectiveness.
Paper TMF requires a lot of space, and the space is expensive. The cost may vary from city to city and from country to country, for example, in central London, the average monthly cost per foot is around £72,5/ €83/$90, and you will need at least 10 feet to keep the smallest TMF well-structured and in place.Rental price is only a tip of the iceberg. In addition to that, you have to consider all requirements for the storage of paper documents (e.g., having an automated powder-based fire extinguishing system), and the costs are over the roof.Flex Databases offers 10 free GB of secure and damage-protected cloud storage, and a big percent of our TMF clients have never exceeded the free limit.
To keep paper TMF going, you need to spend money on paper, ink, staples, binders, and the list can go on forever. With our eTMF, the only thing you need to add, create, edit, send, review, and approve a document is your laptop and/or phone.
TMF security is a big thing and a big cost. For example, an EMA Guideline on the content, management and archiving of the clinical trial master file states the following:
The TMF should be managed securely at all times to ensure completeness and to prevent accidental or premature loss, unauthorised alteration or destruction of documents. Access to the TMF should be based on a role and permission description that is defined by the sponsor and/or investigator/institution.
The sponsor TMF and investigator/institution TMF may contain some information that could unblind personnel who need to remain blinded during the trial conduct. This should be appropriately controlled, e.g. storage of the documentation in another system or repository and/or by a role and permission description that is defined by the sponsor and/or investigator/institution.
Ensuring the required by regulators level of security for paper TMF is incredibly expensive. However, with our eTMF, you don’t need to pay anything extra – and we can set up any required by regulations access permissions simply and for free.
With our eTMF, companies can save not only the obvious apparent costs from moving from paper to cloud yet man-hours, which are way more expensive. There are several features that make our eTMF able to do so:
| A powerful search engine | Find any document in a couple of clicks without any dependence on how old the document is – no more time is wasted on diving through the paper avalanche. There’s more for it – a user can add all important documents to the “My Favorites” section and don’t spend any time on the search ever. |
| Notifications | Notifications based on metadata events, such as expiry dates, help to keep eTMF relevant and save time from following multiple trackers – the system will tell when there’s a need for action. |
| Optical character recognition (OCR) | No need to re-paste paper documents – just upload the file, and the system will recognize any text on its own – it works with both scans and pictures |
| TMF Activities tracker | Be always aware of what’s done, and what has to be done, so important tasks won’t be missed, and there will be no need for double work or spending time on human-factor based errors. |
| Simple audit preparation | Full audit trail, automated folders completeness statistics, and missing documents reports ensure constant inspection readiness. |
Of course, there is more. We can keep the list going forever, but to keep it simple, there is a fact – eTMF saves money on storage, print, and, most importantly, makes your processes more efficient and save money on man-hours.You can redistribute the workload to more important tasks aside from the TMF maintenance, as the system mostly takes care of it itself.
If you are looking for a cost-effective, simple, and secure solution – you have reached your destination. Request a demo through our website or send us an e-mail to bd@flexdatabases.com to know more and start saving today.
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.