If you have attended any clinical trial conference in the last 2 years, you have heard about Risk Based Monitoring. You have heard people talk about being detectives, looking for trends, and centralized monitoring. But if your experience has been mine, I am always left wondering what tools there are to do this.
Having worked on the sponsor side of the industry and managing the Clinical Operations for a small medical device company, I was on my own how to effectively remote monitor a study to be able to manage the monitors time on-site and identify which sites were the highest risk. We reviewed the data in fairly real-time of entry, we engineered tracking to identify trends, and was able to spot issues before they were issues. But it was still a lot of work.
It seems that everyone agrees that RBM is a really good concept, it saves time, money and improves data quality. But no one seems to be able to tell you HOW it can be implemented or WHAT can help you to make the most of the concept.
I recently started working with a small software company called Patient Profiles. I wish I had Patient Profiles during those studies!
They have a combo of solutions that not only help you to look at the data for a single subjects, but does the work of spotting outliers and anomalies in the data itself. Having a tool that actually supports RBM and help you to focus on what subjects or sites need attention, versus just looking through data and waiting for something to jump out at you makes all the difference.
Patient Profiles is a solution that I am personally very excited about and realize that they have the opportunity to make a difference in the conduct and data integrity of clinical studies.