Intense interest surrounding RBM shows alignment of all the right elements — technology, regulatory bodies and the industry itself – to make risk-based monitoring a reality. If implemented with the right components, this approach could result in the most efficient trial management possible.
The current state of RBM and how to implement a successful program are explored in a recent article I authored for the December 2014 edition of EPC (European Pharmaceutical Contractor), entitled Risk-Based Monitoring: A Little More Action. We begin with a look at the EMA definition of quality risk-based management and how it sets the foundation for successful RBM, grounding us in why we're doing RBM in the first place.
We also examine the Quality by Design (QbD) process as it provides a clear understanding of your study risks. It's this QbD process that sets you on course to take action and mitigate risks through monitoring. It also enables you to adapt your plans moving forward.
Intelligent risk-based monitoring employs a robust quality process backed by technology to help make sense of the thousands, if not millions, of data points in a trial. To ensure you have the right tools to implement your RBM method, there are some important considerations when evaluating technologies. These include integration ability, data types and sources, KPIs and other factors, all of which are discussed in the article.
One of the major stumbling blocks to RBM I'm seeing with organizations both in the US and Europe is an exhaustive search to find the best monitoring method (when in fact there is no single best method!). While factors like these pose barriers to implementation, the good news many resources are available to help you overcome them so there's no time like the present to get started!
Preview Compass Technology
If you'd like to preview BioClinica's RBM-enabling Compass technology, an on-demand webinar is available to watch at your convenience. In it we explore the Intelligent Monitoring approach aimed at raising overall clinical trial quality while reducing risk. I encourage you to watch it if you're having trouble moving your program forward.
In the meanwhile, if you'd like to talk about RBM or need an answer to a specific question, shoot me an email at Courtney.McBean[a]BioClinica.com and I'll walk you through it. I'd love to hear from you about what is, or is not, working for you in your own clinical trials.