eTMF Implementation

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Software + manpower

Getting your study submission-ready

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.

Choose from our full-service offer or stand-alone services

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:

  • Full-service suite including eTMF
  • Stand-alone eTMF services
  • pTMF to eTMF conversion
  • Dedicated team working with sponsor’s Vault
  • Inspection readiness checks, extra checks and quality reviews of existing eTMF

Our advantages

Regardless of the service you choose, we ensure success by providing the following advantages:

  • Dedicated central reviewer team
  • Trained project leaders, CRAs and CTAs in multiple countries
  • Processes and technology such as Veeva Snap to drive efficiency and eliminate errors
  • Metrics and markers to detect errors and gaps in eTMF on an ongoing basis
  • Final review with eTMF specialists to double check for quality

Metrics

Let us help you leverage eTMF

Contact us

Gain immediate visibility into trial status, trial process and TMF quality by leveraging our eTMF offer. We’re looking forward to discussing your needs.

Contact our teams