Did you know that eTMF exchange mechanism can help with system interoperability? It can centralise the exchange of data so that a CRO can leverage their system and a sponsor theirs.
Ahead of the TMF and Inspection Readiness Forum 2019, we spoke with Rebecca Halbur, Senior Manager, TMF Systems at Biogen about the biggest challenges with interoperability and migrating systems , and how to address those challenges using processes such as the eTMF exchange mechanism.
In our exclusive conversation, Rebecca reveals lessons learned, as well as Biogen’s strategy to ensure their TMF system is inspection ready.
We interviewed Head of TMF Operations at Pfizer, Marie-Christine Poisson-Carvajal and asked her how Pfizer ensures the quality and compliance of their TMF across different trials and users with an in-house Quality Management System (QMS). In our exclusive interview with her, she gives her top tips on how other companies can create robust TMF processes even if they don’t have an in-house Quality Management System. She also explains why it is critical to building a good team who can bridge communications between internal and external operational groups.
DOWNLOAD THE FULL INTERVIEW and benchmark your TMF approach.
With regards to making your TMF inspection ready in 2019, we conducted an industry-wide survey to understand the key areas and TMF trends for the next 12 months. This infographic aims to answer these pain-points:
- What TMF challenges are being faced by the industry?
- What type of TMF solutions are companies interested to use to overcome those challenges?
- What areas will be their main focus, in order to optimise their TMF system?
Download this hot-off-the-press infographic and find out where the industry is headed!
This infographic was made ahead of the TMF Inspection Readiness Summit, taking place in Belgium (17 - 19 September 2019 )
Find out more about the event by downloading the agenda here.