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Electronic trial master file

Electronic trial master file

Search complete. 4 mentions across 3 episodes found for "Electronic trial master file".

Sep 23, 2026

Vivienne van de WalleGUEST
17:29
Um, w- we least, we do see improvements, and what more so, and I think that that is for me the return of investment when I, when I do these things is, as I say, we don't know what we don't know, and then they realize the things that they don't know, and that's when they have to reach out to the site to get that feedback.
Vivienne van de WalleGUEST
17:50
So they might not have integrated everything into that new trial that we were conducting, but I did see an awareness within that company that they continuously now are collaborating with me and other sites on every step along the way, whether it is implementing of an eTMF, whether it is, you know, um- What EDC works best for you? What vendors do you like working with? What vendors are, are a struggle to work with? Which help desks are, are good for sites? So it's literally not only a protocol input, which is crucial to have for sites and, and patients to say, you know, "This, this is feasible in the protocol, and this is not feasible." But you can have a very good protocol, but when everything around it is not functioning in a good way, when the IXRS and the EDC and the eCOA and the ePRO and everything else is not working very well, then you're still struggling.
Vivienne van de WalleGUEST
18:50
So, uh, now I see those sponsors that we talk to understanding everything else around it, because everything else around it, when that's failing us, whether it is a courier that's not taking a day to take our blood samples from here to the lab, but takes three days to get it to the lab, meaning that these are old lab samples, and then they are thrown away, it is still considered a protocol deviation at my site.
Vivienne van de WalleGUEST
19:18
But I never chose the, um, courier service, and it's the lab that did that.
AshtonGUEST
21:18
You go there, it's a one-stop shop.
AshtonGUEST
21:21
So what I was sort of forced to do in order for me to compete with those guys is that I needed to partner with others, eTMS vendors, eTMF vendors, IRT vendors, other service providers like, you know, boutique CROs who can provide the services because, you know, When I was at Metro, I think they do now, we didn't have a professional services team who can actually build up the database for people.
AshtonGUEST
21:42
so just over the years i've just pushed business over to them referred them i've also started what we call a cro partnership program um at managerial and also at caster so this is a program where we were referring cro's that knew how to use our platform and referring business to the cro so just over the years i developed pretty strong network of people because you know who doesn't like someone who's referring the business right so you know when it came time for me to start my own business you know they were essentially the buyers you know, I guess I collected the payments, right? Hey, I'm building something, you know, I'm not asking for you to buy the product.
AshtonGUEST
22:18
Can you, you know, work with me and being a design partner and building a solution? Well, first I asked him, is this a solution that you find, you know, useful, like exactly the way, you know, did with the mock up.
Jimmy BechtelHOST
17:14
I'm sure we'll end up talking about it and being in the same room when those conversations continue to happen.
Jimmy BechtelHOST
17:18
But as we move to start to close our conversation here, Catherine, my final question is, as you've moved from eTMF pass rates from a, a place of sixty-five percent to nearly ninety-nine percent across the network of sites that y-you have in the technology system, with over a hundred and seventy-three billion in research assets licensed out to China last year-
Catherine GregorGUEST
17:41
Mm-hmm
Jimmy BechtelHOST
17:41
...
Catherine GregorGUEST
18:07
So I think it's going to be more sites doing more studies and still having smaller portions of patients to manage across them in order to beat speed.
Catherine GregorGUEST
18:14
But it is going to be leveraging technology and AI to help the people on the ground in front of those patients move faster.
Catherine GregorGUEST
18:21
So eTMF pass rates means that basically the site has put in a document, they're able to get any queries resolved in real time.
Catherine GregorGUEST
18:28
We're not waiting six weeks between monitor visits, so they can see it electronically.

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