32% of FDA submissions have critical data conformance issues. Clearing up these issues delays market approval for vital drugs. You need to understand your studies holistically so that you know you’re inspection- and audit-ready.
We use Veeva Vault, the market’s leading eTMF software, and augment those capacities with our best-in-class processes, procedures and implementation experience. You know that your studies are backed by the best.
To be submission-ready, your Trial Master File needs to be complete, consistent and accurate. We create a TMF plan, upload your documents review them for quality and ensure they are inspection ready. Then we archive them using Veeva’s eTMF software to make sure your documents are readily available when you need them. We can take care of every step or just one. Choose the offer that works best for you:
Regardless of the service you choose, we ensure success by providing the following advantages: