Driving a Culture of Innovation and TMF Inspection Readiness

Advanced Clinical’s JP Miceli has been on the forefront of TMF management and quality improvement processes for nearly 20 years. Advanced Clinical is a global contract research organization that specializes in managing and supporting Phase I-IV clinical trials across all major therapeutic areas. As the director of document management, Miceli is responsible for all contract research organization (CRO) and functional service provider (FSP) TMF activities, staff, project management, business development, and budgeting, as well as TMF migrations, implementations, and system deployment. In a recent interview, Miceli reflected on the digital transformation of the TMF process, why TMF excellence is so critical, and the importance of continuous innovation.

You implemented Veeva Vault eTMF in 2013. Can you tell us about that journey?

In almost 10 years of use, we’ve transformed from a company that managed mostly paper TMFs to one working almost exclusively digitally. This has allowed the organization to expand its reach globally, manage a larger number of TMFs, and increase TMF visibility for sponsors. Customers of Advanced Clinical expect documents to be processed in a timely manner and with a high level of accuracy and completeness. They’re also looking for real-time transparency into what’s going on within the TMF. They get regular updates but also expect to view status in the system, and having a streamlined workflow for document processing helps Advanced Clinical achieve these expectations.

You mentioned real-time access to TMF documentation. Why is that important?

It really comes down to a high audit or inspection risk. If TMF activities don’t happen in a timely manner, or the sponsor doesn’t know the status of the documentation, that puts the overall trial at risk. Documents should be in the TMF whenever they’re available, not just by the time the study is over, or there is a risk the TMF is in a deficient state.

You are constantly looking for ways to drive innovation and improvement into these processes. Can you tell us about your recent experience adopting Veeva’s TMF Bot, which uses artificial intelligence to streamline TMF management and improve quality with automated document classification?

We adopted the TMF Bot to automate the document classification process to reduce manual errors and allow users to spend time on more critical activities. Having to go in and manually select a classification for every single document can be extremely time-consuming. When the system can automatically do that for you, it drastically reduces the number of times a person has to go in and figure that out for themselves. It increases the accuracy of how documents are classified, and the document management team spends less time processing documents due to fewer misclassifications. Overall there is greater speed, better accuracy, and improved quality throughout the document lifecycle.

Can you quantify the results you’ve seen since adopting the TMF Bot?

By our estimates, Advanced Clinical saves up to four hours per week on document processing activities with the TMF Bot enabled. Without having to manually assign a classification, the document management team processes documents approximately 30% faster. That is invaluable. To have those extra hours each week to focus on other critical TMF activities is huge for us.

What would you say to other organizations that are considering the TMF Bot? Any advice?

The implementation is really straightforward and simple. I think there may be some people who are still a little nervous about automating document classification, but I tell people it is a benefit to the overall process and TMF inspection readiness. The risk is extremely minimal because a human still reviews the document before final approval. So, if for some reason the TMF Bot misclassifies something, it will be flagged through an internal business process as part of a quality control review.

Why is this type of innovation important to you and your work at Advanced Clinical?

We have put the tools, systems, and processes in place to deliver the best quality TMF to our customers. And to continue to be successful, we need innovation to continue happening. On Veeva’s end and on our end. We all have the same goal in mind – to make TMF management more straightforward, streamlined, and simplified for our customers. Especially when, historically, the TMF has always been an overlooked area of the overall clinical study life cycle. With technology innovations like the TMF Bot, as well as ongoing process improvements, we can increase the strategic importance of TMF and ultimately accelerate clinical trials.

Learn how automation with Veeva’s TMF Bot can help you improve inspection readiness.