We at CIMS have a long history within the pharma and biotech business. We have over the years come across many companies that have asked for our advice for eTMF systems. For those not familiar with the term eTMF it stands for electronic Trial Master File.
A trial master file (TMF) is the collection of essential documents that is used for the management of the trial and used to verify whether the sponsor and the investigators have conducted the trial in line with the applicable regulatory requirements and the principles and standards of GCP. Therefore, the eTMF is simply an electronic version of a TMF.
It is somehow the nature of humans to build systems and when talking about digital information, digital systems are developed. That’s also the case for eTMF systems. However there has been a tendency to build large and complex systems for exactly this kind of software. This has left a large amount of small and mid-size companies high and dry when needing an eTMF system.
That was the reason for us at CIMS to start developing our own version of a dedicated eTMF system. By choosing a well proven platform, combined with agile system development we were able to launch our CIMS Clinical eTMF system which targets small and mid-size pharma and biotech companies.
Now you may think since the system does not require 3-4 FTE to maintain there must be a snag! The short answer is: There is not!
CIMS Clinical eTMF system is in full compliance, is validated, has electronic signature, is easily customized, uses state of the art backup, and has enhanced security with full encryption.
It is built to do exactly what it is expected to do.
Any data handling involves the risk of data loss. Therefore we at CIMS have developed the system, so our clients can request a physical data copy delivered on a real harddrive. Furthermore we are obliged to deliver the data back to the client if the client wants to go for another solution.
Here CIMS has made the system our customers right of ownership. The CIMS eTMF is backed up every second hour and data transfers can be made to the client on a regular basis. Therefore, our customers can sleep well at night without having to worry about what will happen to their data if something goes totally wrong.