TMF Summit Insights: People Make the Difference

Members of the Daelight team recently attended ExL Events’ 9th TMF Summit in Orlando – and they came back with a few key takeaways gained from the informative sessions and conversations with people who manage the Trial Master File (TMF) every day.

The insights were numerous, but a theme began to form: People throughout R&D want to focus on their job and less on the task of collecting and approving documentation to build the TMF.

That may sound obvious enough, but the reality is that many colleagues look at building the TMF as additive work to their primary focus – a distraction from what they really need to be doing.

Managing the TMF With Technology

Most companies have either installed sophisticated technologies to manage the TMF better or are in the process of doing so. Just about everyone agrees that these technologies provide tremendous benefit by improving efficiency and ensuring inspection readiness.

However, building the TMF requires a multitude of documentation across several organizational functions, many that work in systems outside of the TMF. It is interesting to note that the benefits gained from the latest technology implementation do not always adequately address the needs of people and their processes.

Solving TMF Technology Challenges

At the Summit, there was a lot of wonderful dialogue looking to solve these challenges. The event offered sessions that considered solutions, such as machine learning and artificial intelligence. Conversations during networking breaks often veered to this topic as well.

Everyone seemed to be saying similar things:

  1. They do not want the TMF to be a disruptor
  2. People should work in the system designed to support their job
  3. There must be a more seamless and automated way to build the TMF to realize the full ROI of the technology

Indeed, machine learning, artificial intelligence, intelligent integrations and other technical solutions will answer these challenges. Traditional TMF technologies – including Feasibility, SSU, CTMS, Regulatory Submissions and Site Investigator Portals – are also evolving to manage associated functionality, which will go a long way to help solve these challenges.

With that said, it is imperative to take a step back and consider the people. The people who are affected by these technical implementations are paramount in the technology’s success.

Start With People

Do you have a solid R&D technical roadmap?

When outlining your technology implementation, start with the people:

  1. How do they work?
  2. What technologies are they are using?
  3. What are their priorities?
  4. What challenges do they face?

By answering these people-centric questions, you will gain a more holistic view of all stakeholders and end up on a seamlessly working path.

It will take some time to get there, but every journey starts with the first step. Perhaps, the first step is to change our perspective on the TMF. Stop thinking of it in terms of structured documentation and technology to support it, but in terms of all the people who have input building it.

Let people work the way they like to work. To minimize the impact of document collection along the way, look at the larger landscape, review your processes and, most importantly, involve people who are in the best position to help you understand the implications of any future technical solution. Those people make the difference!