Organizational Change Strategies for Sustainable Trial Master File Management

Are you or your colleagues facing never-ending issues when being audited or inspected? It might be time to start putting your (clinical) house in order.

As previously discussed in our Blog Post, Be a Good Student: Get Your eTMF Prepared, the current trend we see among our life sciences clients is that they are starting to change the way they manage their clinical Trial Master Files (TMF). A significant percentage of them have started, or are already in the process of, transitioning from distributed passive TMF practices to automated central active TMF management. In other words, they are changing the way they work to a more “modern” electronic management of clinical TMFs (eTMFs). Their motivation is usually twofold: one, achieving compliance with regulatory requirements; and two, improving efficiency.

However, our best practice framework supports a third factor that is often neglected and that is needed to successfully achieve a sustainable transition. That is the “how.”

With that said, you might be wondering how to deal with the complicated mess you’re in. Don’t worry. At HighPoint, we take it step by step. Our methodology starts by defining your current state, as simple as, “Where am I?” and “What does my house look like?” We answer these questions through an honest discussion with all stakeholders and by identifying the documentation and the data in scope to establish accurate ownership of data. Following this assessment, we then arrive at specific suggestions for future improvement, as well as specific solutions for delivering on those future improvements.

Of course, no one size fits all. Generally, depending on whether you are passive or active when it comes to managing your TMF, you will face a number of challenges that must be rectified. But what is common to all organizations is that imposed change rarely works. Far too often, business transformations concentrate on strategies and process reengineering, while ignoring the most important aspect of change: the people. It’s critical to involve stakeholders through the entire journey and to adequately manage communication among them. Be patient too. Changes to your TMF management will take time. If you succeed in raising people’s awareness and get them engaged, you will significantly increase the chance of achieving a sustainable transition, short and long-term.  

Remember, when moving forward, always keep in mind the key objectives of your eTMF initiative: one, ensuring compliance with regulatory requirements; and two, improving efficiency. In addition, do not fear the deep dives. Gaining an honest understanding of your people’s needs and diagnosing any potential barriers they might encounter when adopting new processes or technologies is worth the commitment to those discoveries.  

To learn more about real-life scenarios we typically come across with our clients and the recommended strategies for sustainable TMF Management, read our latest article, “Clinical Trial Master Files – Don’t Fall into the Trap of Making Compliance the End Goal!” (page 40).

You can also contact Alaitz de Eguia.