With regulatory agencies placing greater emphasis on risk-based monitoring (RBM) in clinical trials, the use of tools for RBM has become more and more crucial to success within the industry. If you're considering adopting an intelligent monitoring solution or if you're in the early stages of implementing such a tool, it's important to set yourself up for success early on by keeping a few things in mind. In my experience working with customers to implement Compass, I've learned a few key criteria that companies should consider to ensure RBM success.
1. Training the team on the RBM system
Implementing an RBM system isn't a short process; it's a thorough undertaking that will be a significant aspect of making your trials run successfully. That means that all of your internal stakeholders and your vendors need to be on the same page about how the system will work. Make sure you take the importance of training and education into consideration when you're starting an RBM project as well as throughout the project. Not only will you will need to educate your team about the software itself, but you will also need to make sure they know how it will impact them and their work. Implementing RBM is a substantial commitment and often a considerable change from current processes and approaches. If your team members aren't aware of what their role will be in that improved process, they won't understand the time commitment necessary to make the project successful.
2. Defining the success criteria for the RBM project early on
As with any new project, it's important to determine early on what you and your team consider to be success. It's particularly critical when implementing a new approach to clinical trial management. Defining specific and measurable success criteria helps promote the value of using RBM software to the rest of your team and will also guide you to conduct future trials even more effectively. By having clearly defined success criteria from the start, you can look back on a trial to determine what went well and what didn't and how improvements can be made in future studies.
It's important to set your success criteria at the beginning when you're formulating your monitoring plans, statistical plans, risk plans, etc., because all of those plans will help you figure out what success means to you in the project and how to measure it. We recommend clients utilize the "SMART" approach in determining success criteria: Make sure your criteria are Specific, Measurable, Aligned, Realistic and Time-bound. Outlining what your team will view as success will help you not only with your current study, but with future studies as well.
3. Keeping outside vendors in the loop
When implementing RBM software, it's not just your internal team who will be affected. Don't forget to include all of your external vendors too. Your study will be most successful if you communicate with them about the new RBM processes early and often so you avoid any last-minute confusion when it's harder for them to make adjustments to meet your RBM methodology. This approach will also provide the vendors with added insight about how RBM will benefit their work right from project start.
For example, you may work with a CRO who has monitored several studies for your company already and who may assume that the next study will be business as usual. It's important to make sure they are aware of how their work, their schedule and the tools available to them may change as a result of implementing the RBM processes, tools or software.
Keeping these considerations in mind will not just help your implementation process run more smoothly, but will also ensure that your reliance on RBM in future trials will continue to deliver successful output and results.
If you're interested in learning more about Compass for risk-based monitoring, you can download our data sheet. Bioclinica's Professional Services suite of offerings have a variety of education tools to help with your awareness and/or adoption of RBM into your company as well; you can download our RBM handout here to learn more. And if you have any more specific questions, feel free to email me at Lukas.Jaakson@bioclinica.com.