This highlights a serious concern in the gap between what the regulatory authorities are looking for from RBM and the way in which RBM is being practiced. Triumph Research Intelligence (TRI) have engaged both the MHRA and FDA during the design and development of their operational platform for quality oversight and RBM, and during those discussions heard loud and clear that RBM is process which starts before trial execution, continues through trial execution and results in a trail of oversight activity. Within TRI we call this trail the ‘quality story’.
The quality story starts with the risk assessment (referred to as the risk assessment and categorization tool, or RACT by the Transcelerate group). It continues with the risk management plan (referred to as the integrated quality and risk management plan, or IQRMP by the Transcelerate group). Your RBM platform of choice would ideally allow you to capture the essence of those documents and the decision making process that sat behind them. As your study then proceeds to go through the process of risk identification and management, the observations, actions and outcomes of those actions also need to be captured, ideally centrally by your RBM platform.
The regulatory authorities then expect to see evidence of whether you needed to adjust the plan or not. If you are accurately identifying risk, managing that risk and seeing a positive trend in the quality of data coming out of your sites, then keep doing what you’re doing. If you’re not, then you need to determine why, and adjust the plan accordingly. Your RBM platform should be able to capture the evidence of the quality trending at each site and the decisions you’ve made regarding adjustments to your quality plan.
If you are doing all those things, and have a platform which can simply and instantly provide the centralized evidence of all those things, then we are absolutely improving our inspection readiness. So why are only 35% of companies getting this key benefit of RBM?
I expect a big part of it is that companies are looking to BI vendors and home grown solutions to try to meet the needs of RBM with as little investment as possible. A combination of BI, Excel, Word, and Sharepoint (to quote some of the commonly used desktop tools we see being used) for example may allow you to assemble some of the bare bones of a true RBM capability. But why would you go down that route when there is a far more capable, simpler and cost effective route………The OPRA solution from TRI delivers the inspection readiness support, coupled with ease of use, centralized identification and management of quality risk at a cost way lower than the development of a home grown solution. Well someone had to!