iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
This summer Flex Databases and Faron, a Finnish biopharmaceutical company, signed a contract for eTMF implementation.
We’ve asked Maria Lahtinen, Director, Supplier Management at Faron, a couple of questions about the new partnership:
Why Faron decided to implement eTMF? What was the starting point for digitalization?
Faron had two aims for the project – to have a Faron-managed TMF system and to have it as an electronic format. The main driver for the system implementation was to have better oversight for Faron sponsored studies. So far, Faron has used the eTMF systems managed by CROs.
Why Faron selected Flex Databases as a software provider?
Faron needed to find a software provider capable to fulfill all different requirements (technical, data security, validation, user experience and co-operation requirements). We also needed a software provider ready to guide us through the set-up and implementation of the system; with a team readily available to answer all manner of questions that arise through the process. We were looking for flexibility because all study-specific requirements were not clear for us when we started the selection process. The time for the set-up was also limited because we wanted to have the system in use very quickly for our upcoming studies but with strictly qualified process.
What do you expect to achieve with the implementation of Flex Databases?
Interactive approach to allow review of study documentation at any point in the lifecycle of each of our studies. We were aiming for better quality management, quicker processes and audit readiness. A key element was the feeling of confidence that we are on track with all activities and that our study is proceeding well, in a compliant way.
Faron is a clinical stage biopharmaceutical company focused on building the future of immunotherapy by harnessing the power of the immune system in order to tackle cancer and inflammation. Since its founding in 2007, the company’s goal has been to develop a diverse and unique pipeline rooted in high-quality science and innovation. Faron is focused on mastering immune modulation by harnessing endothelial receptors to control and mediate immune responses.