Brent Sorrells, Director of Clinical Operations
Allakos is a clinical-stage company developing a new antibody for chronic allergies. And as a clinical stage company, one of our major milestones will be achieving FDA approval. In order to do that, we’ve implemented tools. One of the main ones being the Vault eTMF. Our whole focus is on making it through a pre-approval inspection and so we needed to know quickly where we stood on every study.
When we were looking at an eTMF solution we looked at several different offerings, but it really wasn’t until we saw the demo of Vault eTMF that we realized what an eTMF could be. The ability to easily identify documents you needed in the TMF as well as customizable workflows to get those documents in and assess their quality.
For me, the biggest feature was just the reporting abilities within Vault. Being able to quickly customize your report to dig down and solve a problem, but then also take those reports and put them into customized dashboards so that problems can easily be identified and consumed by those higher in the organization.
Vault eTMF has helped us with inspection readiness by really giving us the ability to check our status at any point during the studies. We’ve actually gone to steps to create customized reports that help us align our content with the BIMO guidance for FDA so we can see from an inspector’s point of view how they’re going to organize that content, how we match up against those requests coming from an FDA inspector. After we implemented Veeva Vault eTMF, we saw very quickly we had a lot more visibility into the activities of the study. And we were actually able to speed up our study startup by being able to identify which documents we needed from each site in order to activate them. And so, we were able to be a bit more proactive, because our CRAs and our project managers were well-informed with the documentation we needed.
For Allakos, I think our next steps with Veeva are obviously to continue implementing the new features that come out for the eTMF. Personally, I would love us to adopt more products just to streamline the overall efficiency of the organization so we can have a single login that gets us to Quality and to CTMS and EDC. And I can certainly see the advantages of having all of those systems under one umbrella, communicating with each other.