Laying the Foundation

What You Need to Prepare for to Bring the TMF In-House

In episode 2 of our seven-part Podcast series: Bringing 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.

Here’s what you will learn:

• If an organization has decided that they want to manage its TMF internally, and they have not done so previously, what is the first step?
• What about budget requirements? What are some of the cost factors? And how do you justify it?
• What would you say to someone at a manager level who is certain this is the right move but does not have the authority to make it happen? How do you get executive support?
• Is this a transition that starts with one study first? Or is it an initiative that could include transitioning the TMF responsibilities for several studies?
• What if they do not have the expertise in-house? Should they hire someone specifically for that role?