Risk Based Monitoring in 2017


Risk based monitoring is a recently new innovative technology and strategy adopted in the clinical research industry and is quickly gaining some steam.  It has already begun to cause quite a disruption to the status quo in the industry. I know from first-hand experience as a contract CRA, a study I was just working on recently switched to remote monitoring as well as risk based monitoring, and I was removed from the contract. This is going to be an all too common scenario that research clinic industry professionals will need to adjust to.

I previously had a conversation with Darshan Kulkarni which you can find here, where we discussed Trump’s impact on the clinical research industry and what that may mean for emerging technologies such as risk based monitoring. Whatever the case may be, it is clear that the clinical research industry is full steam ahead with the risk-based approach. Remote monitoring is often confused with risk based monitoring but they are not interchangeable words. Remote monitoring is simply a tool that allows source dara to be reviewed remotely, and may or may not be used for risk based monitoring or traditional monitoring. Risk based monitoring is a strategy in which sponsors take a more centralized monitoring strategy that does not require 100% source data verification of study data.  With the emergence of big data and robust study analytics tools, savvy CRO's and sponsors are able to assign a risk profile which can be modified in real time to address the research sites’ particular needs. Not every research clinic will have the same monitoring strategy as was common practice in the past.  

As with any emerging technology there will be winners and losers. The CRO's, sponsors and research clinics that are able to adapt, while leveraging these new technologies, will succeed, while those who do not will simply fade away. As with most changes in our industry they often take time to develop and become adopted. Risk based monitoring has practically become a household name of sorts in this industry. There are many industry vendors emerging that are looking to capitalize on this new technology. I've interviewed the CEO and founder of Devana Solutions which uses technologies to streamline a research clinic’s particular business development strategy as well as keep internal metrics on the research clinics which are often used by sponsors and CRO’s to assess a particular's research clinic's performance.  This will ultimately determine whether that particular research clinic will be awarded any future trials. I have also interviewed the chief commercial officer from Drug Dev.  In that interview we discussed a number of things, risk based monitoring being one of them, you may watch that video and read that article here. There are also virtual workspaces such as Intralinks VIA, which allow research sites, CRO's and sponsors to seamlessly collaborate on work occurring during the study such as trial master files (which hold essential regulatory documents from each research clinic that is participating), contracts and budgets, sponsor, CRO and CRA communications with sites, and not to mention complete source documentation and medical history for all study participants stored in a HIPAA and FDA compliant secure cloud server. I will soon interview Andrew Mitchell who heads up product strategy and marketing for Intralinks VIA shortly.  In the meantime, I will be on an upcoming webinar March 15 and the link is here so you can register for free. During this webinar we will have experts from the regulatory side of the clinical research industry attempting to explain how changes to recent good clinical practice guidelines will affect all of us in the research industry. I hope to see you there and answer some of your questions. 

No one can predict the future, however, because changes occur relatively slowly in our industry, we can be proactive and plan ahead so that we are not left behind but rather we position ourselves to utilize these new technologies to obtain more marketshare and strengthen our positions in the industry.

For those that would like to know how risk based monitoring will impact research sites, check out my video here


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