TMF Management: The Project Plan to Bring the TMF In-House

by | Feb 9, 2022 | Blog

We’re continuing our discussion on how sponsors can successfully bring management of the trial master file (TMF) in-house. This discussion is part of a seven-part podcast series that Ken Lownie, Agatha’s head of North American Operations did with Janine Penman, Founder and CEO of JPScientific, Inc.

As Ken points, it’s not an all-or-nothing situation, and it’s not a matter of getting rid of the CROs. Sponsors have different reasons for wanting direct management and control of the TMF. And in this post, we’re talking about the project plan and four key components. (Note: Part one in this series is here.)

Building the TMF Management Plan

There are four elements to consider when putting together the project plan to bring the TMF in-house: people, budget, process, and technology.


Janine said sponsors could do this project with the staff they have. Even if they are running a very lean clinops staff, armed with the right processes, they can do the work themselves. The question is, do they have the expertise? Do they have the processes in place to manage the TMF? This is where a sponsor could consider getting outside help from a consultant to get them started and train their employees to take over the work.


The next element is budget. Does the organization have the budget available to support internal TMF management? Technology is a key component of the budget, but there are other line items to consider as well, including: Programmers who can build configurable workflows (when enterprise, highly customizable tech is implemented) Other external consultants to help support the technology implemented Other line items include the time and cost to implement the technology and support the technology going forward.

“On the technology side, I hear what you’re saying because a typical technology initiative has two very clear and distinct costs. One is the technology itself; I need software; maybe if it’s old-fashioned, I need servers. But the second is I need to implement the technology. And what I worry about is that people are used to the old-fashioned technologies, let’s say the 1990s technologies. So I need $100,000 or more for the technology. And I need $100,000 on top of that for a six-month or eight-month project to implement it. And you and I know that that’s crazy. That’s not necessary anymore.”

– Ken

Janine said sponsors should see a decrease in budget requirements because they are self-serving the TMF going forward. It can be challenging to see TMF support items in a CRO budget, but if you look for specific line items, you see where moving the management of the TMF to the sponsor eliminates these items.

“Within a CRO bid grid, will there be a line item that says TMF management? Again, it depends on the CRO. It’s unlikely that it’s going to be that clear. Often, you’ll see it worked in other places like study startup or project management, or there might be a TMF group, but it might be called business operations. So it can be a little tricky to find those line items, but they’re definitely in the CRO’s bid. And there is definitely budget allocated, usually a significant portion, I mean, six figures, in most cases, allocated toward the implementation setup and support and eventual reconciliation of that TMF.”

– Ken


The third is the process. Ken asked Janine to talk about the process to transition a sponsor with five studies to in-house TMF management. Janine said the process depends on how the sponsor is managing its studies.

If there is one clinical operations team managing all five studies – this is the simplest scenario, and you could migrate the TMF’s for all studies as one process. Still, Janine recommends doing it in stages to make things easier. However, if different groups manage each trial or there’s a combination, it’s better to migrate one study at a time.

“If different teams and groups own different studies, then you want to start with one study. Do a proof of concept, get your pilot done, then go to the other teams, and say we’re implementing this, and it is working. And you don’t have to wait until the very end. You want to show some level of progress so that you don’t scare them off from the concept completely; you show them that you’ve made some incremental progress and that it is doable.”

When picking which study to start with, select the newest one, preferably one that hasn’t started and isn’t with the CRO. This first study is the one you will build your model and process on and have all other studies follow suit as they are onboarded to the TMF. Janine said by starting with a clean slate, if tweaks need to be made, you’ll know it’s because of how you set it up and not due to things that happened in the study in the past.

That being said, you don’t have to only move forward with only new studies. Now that you have your process and technology in place, you can move in current studies underway. The key with this migration process into the new TMF is to clean as you go so you have a clean TMF.


Finally, there’s the technology component of bringing a TMF in-house. This episode didn’t go deep into the technology component – Ken and Janine get into this topic in a follow-up episode. The most important thing to understand about the technology to support TMF management is that it doesn’t have to be complex, and it doesn’t have to cost a fortune. 

“Don’t cut yourself off from thinking about this saying it’s never going to happen because unless you’ve looked lately, you might not know those technologies. We’ve gone from a platform model to an application model. And those applications are in the cloud-ready to use and much faster and easier to implement.”

Right-sizing Your TMF Technology Purchase

Janine explained that technology is only one part of the project plan, but it is crucial to think about. She compared technology to a car, saying technology is the car you drive, the process is the way you drive that car, and the road is where you drive the vehicle. So what does that mean for TMF management? The car is an essential piece of driving, but it doesn’t go anywhere without the driver and the road.

“So the people that enable these processes, the people that act on them every day, they’re your drivers, and the road is the process, the tech is the car.”

One Final Note Related to TMF Management and Inspection Readiness

Ken ended the talk with a note about CROs. He said they aren’t bad; they are extremely important to helping sponsors manage clinical trials successfully. But for some sponsors dealing with multiple CROs managing multiple studies, things can get very complicated. And when you start talking about inspection readiness, the complexity of this approach becomes very clear.
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