Why Collaboration is Important to TMF Quality

This is part one in a series about how collaboration can impact TMF quality and inspection readiness.

In the race for a COVID vaccine, we saw amazing collaboration between the private sector, government, and academic research. Collaboration can become a force multiplier for speed and impact, leading to greater productivity, increased efficiency, and better outcomes.

If collaboration isn’t the heart of your solution, your organization will struggle as the trial landscape becomes increasingly complex. Pharma companies are spending more and more on partners and CROs. In fact, some sponsors are hiring multiple CROs to handle individual functions, such as one to execute the trial, one to monitor the trial, one for data management, one for feasibility and startup, etc. With so many hands in the cookie jar, driving collaboration among the increasing number of actors is critical to successfully conducting the study and maintaining the TMF properly.

The importance of the TMF on the outcome of studies is well understood. If trials take longer due to regulatory inspections or poor collaboration, it can significantly impact the bottom line. Some potentially blockbuster drugs could lose tens of millions of dollars due to these types of delays. We see TMF findings becoming more common as well as more severe. Simply having a TMF is not adequate. The quality of the content in that TMF is paramount and must be addressed across the board by all parties, not just individual contributors. This requires a coordinated joint effort as well as oversight, typically by third-party providers. The result should be a collective goal of stronger TMF quality overall throughout the course of a study.

Although managing this collaborative effort can take longer to create and maintain, the increased attention by all involved parties focuses and elevates its importance. The goal is to embrace and drive collaboration to put people in a position to succeed. Overall, the benefits can be significant. You’ll be able to improve inspection readiness, improve compliance, find and implement efficiencies, and maintain a higher level of TMF quality throughout the trial. Collaboration matters and can have a significant impact on your outcomes. Make sure your company is considering its impact and how you can start working towards better collaboration throughout.

So, how do we get there? In the second part of the series, I’ll talk about what steps organizations can take to increase their collaboration capabilities.