How to Identify Your Organization's TMF Maturity & Planning for Growth

Do you know the TMF maturity level of your team? Do you know if they’re starting from the basics, or if they’re organized with a good level of TMF management?

These questions go unasked much too often, and this lack of reflection ultimately turns into one of the primary reasons that teams are not ready for inspection. Knowing your TMF Maturity Model allows you to understand and improve the quality of your TMF, setting you up for inspection success. It is the foundation upon which you can begin identifying gaps and evaluating progress, and also the key to better comprehending the level of experience your team has. Your Maturity Model is the first step in building a successful TMF process.

In this session, we’ll cover:

• What your TMF Maturity Model is
• How to identify your team’s level of TMF maturity
• Using your Maturity Model to find gaps and evaluate progress
• How to plan for growth

Building a TMF Management Process from Start to Finish

Investing in powerful tools, such as an eTMF system, can work wonders when it comes to ensuring inspection readiness. But without a robust process in place, you can wind up making things more challenging for yourself.

When creating a TMF process, it is important to start from the finish line looking back. You must begin by defining your goals and what you wish to achieve, and then develop the steps necessary to attain your desired results. This can include assessing your current process, identifying stakeholders, creating visual flowcharts, and implementing SOPs and WIs that are aligned with not only your internal quality standards, but also regulatory requirements and GCP.

In this session, we’ll cover:

• Key elements for building a TMF management process
• How to set TMF management goals
• Assessing and identifying gaps in your current process
• Identifying stakeholders and creating visual flowcharts
• Implementing SOPs and WIs

Trial Master File AMA: Ask our experts any question

Ever have a burning TMF question that you just can't find the answer for? Don't have the time to scour the internet to get the info you need?

Well look no further. Off the back of a hugely popular session at TMF Week 2022, we're bringing back the 'Ask-me-anything' format for another fireside style chat about all things trial master file. 

We've brought together a panel of experts that cover process, technology, people and regulation to answer any and all of your critical TMF-related questions. 

Developing a Trial Master File Metrics Roadmap

How do you know if your TMF is complete? How do you know if the documents have been filed in a timely manner, or at the last minute?

In order to answer these questions, you need metrics. Tracking metrics is the first step in improving both the control you have over your TMF and the processes that underpin your TMF management. Many metrics can be applied to an eTMF based on different objectives, which is why it becomes necessary to define a metrics roadmap that helps you to understand gaps and develop the most effective strategy to achieve inspection readiness. With a TMF metrics roadmap, you can foster better alignment between TMF stakeholders, giving them a clear and measurable view of the outcomes of your efforts.

In this session, we’ll cover:

• How to figure out which metrics to track
• How to develop a metrics roadmap
• Using metrics to improve decision-making and communication
• Leveraging metrics to improve your TMF process