The Path to Veeva Vault eTMF

I’m Susan Doleman, Vice President of Clinical Development Operations at Replimune. We’re developing products for the treatment of cancer. We have a number of products in the pipeline, and we’re hoping for success in treating cancer.
We’re a company that’s moving really quickly. We’ve got a number of pipeline products that are coming after each other very rapidly, so we really need our TMF to be up to inspection readiness as an everyday occurrence, not an afterthought. So, we really thought that the Veeva system was something that could help us in that effort.
Initially, we had placed our TMF with a CRO and One of the challenges that we faced was, not being able to access information through another provider’s system. It was difficult to manipulate. We didn’t understand their filing structure. It just made sense for us to be able to control our own files, so that we could have information at our fingertips.
Our vision for TMF is really to be able to access information, have it at our fingertips, be able to pull a document that anyone needs at any time and that all of our TMF is organized in the same way across our programs so that we can, have access to that information.
We chose Vault eTMF because we felt like it was best in class. We had looked at a number of different systems. And then, the other key component of Vault eTMF is the integration that it has with all the other systems. Everybody’s looking for a system, single logon and all those things and it just seemed like the best fit for our company so that we wouldn’t have to do a lot of building and patching together different systems.
Our implementation was fantastic. It was fast. It was smooth. It was well-explained. It was pretty painless. My advice for others for implementing is really to make sure that you have enough time, and the right people. We’re very, very small, so it was a challenge just on a day-to-day basis, because we didn’t have enough bodies and didn’t realize the time investment that we needed.
After implementation of the eTMF we intend to incorporate more of the Veeva systems. So, we’re starting CTMS as well as EDC. And again, the key decision was made because we really want to integrate our systems don’t want to build a lot of people entering data in spreadsheets and having to replicate that or not being able to share across different programs. We just need to be able to do that as easily as possible and we just thought that integrating more of the Veeva systems was the way to go.

Learn more about Vault Clinical Operations.