Your trial master file (TMF) tells the story of your entire clinical study, so you want to make sure it’s complete and accurate before the FDA reviews it.
Hiring a third party to review your trial master file is the best way to ensure you’ve checked all the boxes.
However, the cost of a TMF audit can be significant.
IMARC has conducted a number of trial master file reviews over the years. We work with companies all over the country and even across the globe, so conducting an audit often requires travel. That means paying for airfare, hotels, meals and more.
This short video shows an example of the associated costs that may be required for a trial master file review. It’s worth noting that as much as half the total cost of an in-person audit offers no direct benefit to our clients — we’re simply covering the costs we incur to come to them.
As you can see, these costs add up quickly. That’s why IMARC has recently started conducting TMF reviews remotely, by accessing our clients’ electronic trial master file. The process of an electronic trial master file review is simple and much more efficient.
It offers a better value to our clients and saves time, allowing our team to focus on securing compliance while our clients focus on earning approval.
Find out how much your team could save with an electronic trial master file review. Answer a few simple questions to get a quote from our team.