Bethann Schrader-Giancarlo | Karyopharm
We’ve been in elluminate for about eight years. Actually, we started using it as primarily just a data repository and over the last six years have really started building in more of the platform services, starting with Data Central and hopefully working into – we have CDA and we have a CTOA – and we’re also working into RBQM at this time as well.
I work primarily in Data Central. I’m, at the moment, the primary person who’s doing the review in Data Central and it’s – for me – I’m an associate director, I have three studies and I have direct reports. So, it frees me up to be able to go through and do a very efficient review and get it done when I have the time to do it.
There are 17 of us, but we have like 16 studies that are ongoing. Some of them legacy, some of them are closed but still have, you know, activities happening. And then we have studies that are not only up and running but have major deliverables. Working with eClinical Solutions’ data services makes it feel like we have a bigger team.
In most cases it is a bigger team and we’re partnered to do that instead of just having a CRO relationship. It drives value because it frees up our data management group to do the bigger ticket sort of items… working with our medical monitors for oversight. And you know, it helps with our resourcing because although we are a stable department, we’re not a large department.
I’m looking forward to internally implementing Data Central and more of the elluminate platform, so that we can show oversight. You know, right now we’re using multiple different tools to do that, and that’s one of the most important things to be able to establish and prove is that oversight piece. And by using Data Central and being able to utilize the components of it – issues, identification and management and the audit trail that’s associated with that – it’s huge in that, because not only are you doing it from a data management perspective, but you can also get in with comments from your medical monitors and so on and so forth.
It really, truly shows not only CRO oversight from our perspective, but data oversight and medical oversight of the study.
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