Janine Penman joined us for a 7-episode podcast to discuss the process required for sponsors to bring the TMF in-house.
Janine and Ken discuss the things you need to put in place before you bring the trial master file in-house.
In episode 3 of our podcast, Ken and Janine discuss budget and staffing requirements.
Janine and Ken talk about the importance of ensuring the project is adopted and successful.
There’s always a technology element to any discussion about bringing management of the TMF in-house, and that’s what this episode is all about.
Ken and Janine talk about the need to integrate clinical sites in the TMF process to ensure a seamless transition of information between sites and sponsor.
In episode 7, Janine and Ken talk about TMF operations and inspection readiness. This is a must-not-miss episode.