iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials
At the end of 2020 TCD, an African-focused CRO with a full-service offering, signed a contract for eTMF implementation with Flex Databases.
We’ve asked Bianca Oelschig, Clinical Data Sciences Manager/Project Manager at TCD, a couple of questions about the upcoming partnership:
Why TCD decided to pick Flex Databases as a provider for eTMF?
After spending many months researching various TMF vendors we concluded that Flex Databases eTMF was a great fit for TCD. The software is well designed, user-friendly and extremely customizable to suit the needs of various clinical trials. The team from Flex Databases has been very efficient and helpful and we look forward to working with them going forward.
What do you expect to achieve with the implementation of Flex Databases?
We are looking forward to using Flex Databases eTMF module as it will allow for a completely paperless and remotely accessible TMF. This will result in all essential documents being available to be viewed by stakeholders all around the world, keeping all parties up to date on all aspects of the trial at all times.
Triclinium Clinical Development Pty Ltd (TCD) is a Contract Research Organisation (CRO) headquartered in Centurion (Gauteng), South Africa. Since its inception in February 2000, TCD has been awarded over 300 clinical trial contracts, across 16 therapeutic areas, by more than 120, predominantly international, clients. These contracts included single stand-alone audits to full-service contracts and spanned all phases of clinical research from single-dose First-in-Human Phase I trials to large multicentre Phase III, and Phase IV trials.