How Do You Oversee Your CRO's RBM Activities?
In March 2019 I had the opportunity to interview Jennifer Newman, Global Project Leader, Regulatory Affairs/Clinical Operations for Celldex Therapeutics. Newman was once part of the largest implementation of RBM and was able to share insights from her experience. Specifically, she was able to discuss the benefits and challenges of RBM and what companies should be prepared for when adopting the technology. In this video, Newman discusses how companies should provide proper oversight of their CRO when the partner is handling RBM activities.
Click here to see the complete interview.
Transcript
Ed Miseta: If you have a CRO who is handling your RMB activities, are there additional issues companies have to deal with?
Jennifer Newman: That’s a great question. I know there are CROs that have RMB solutions, and I would just caution anybody who is using a CRO as well as their own RBM solution to be aware of vendor oversight. If you are using your CROs RBM solution, what is your role in oversight of that CRO?
You can do it two ways. You can either be very involved with the CRO and be involved when they’re talking about risk and key risk indicators that go on in the study. Or, you could bring in another vendor to oversee your CRO. Then I think the argument becomes a little tricky, because why pay two vendors when you only have to pay one?
From a quality perspective, it makes sense. If you are going to have a CRO and you are going to outsource that piece, you either must remain heavily involved or you have to bring in another vendor. There are independent vendors that will do that.
Miseta: Do you have any insights into how sites feel about this and whether they’re on board with it?
Newman: I don’t have too much in the way of this. I’d be interested to hear if others do, from a site perspective. I know that it does reduce on-site monitoring, which I think sites are usually in favor of. But I have not heard complaints one way or the other, so I’d be very interested to hear if there are people who have had experiences and had feedback from sites, either positive or negative.