How eTMF saves money

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.

Four ways how Flex Databases eTMF saves money

1. Physical storage

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.

2. From papers to printers

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.

3. Security

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.

4. Man-hours

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:

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.