iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
Sourcia, a full-service European CRO, has recently signed a contract for electronic Trial Master File implementation with Flex Databases.
We’ve asked Claudia Gruber, Director Clinical Operations a couple of questions about the upcoming partnership:
Why has Sourcia decided to pick Flex Databases as an eTMF provider?
CG: To foster and allow for our continued growth, Sourcia decided to implement an eTMF system. After screening and testing of several eTMF systems we found the Flex Databases eTMF system to be the best fit for Sourcia as a Boutique CRO. This is due to its simplicity, flexibility and clear structure. Apart from the eTMF system, the setup of the overall Flex Databases system is also attractive to us, since it has modules and offers the possibility to add functionalities to our electronic platform in a stepwise approach, whilst benefiting from one integrated system.
What do you expect to achieve with the implementation of Flex Databases eTMF?
CG: Sourcia is expecting to make a next step towards a paperless office by moving our studies’ TMF deliverables to an electronic format, which will further increase the sustainability of our work. Sourcia will therefore be able to offer our clients real-time access to all essential documents of their studies in a standardized structure within a 21 CFR Part 11 compliant system. Using all advantages of an electronic document management system, we are confident that we can improve the accuracy, completeness and currentness of our TMFs even more, which is a deliverable that every CRO is constantly aiming for.
Sourcia is a full-service CRO tailor-made for Small to Medium-Sized companies. It is a highly experienced, flexible and independent partner in clinical development.