Medidata CTMS-Vault eTMF Integration Has Arrived

Hot on the heels of Veeva Vault’s V10 release, Vault eTMF customers received new capabilities this week with the integration of Vault eTMF and Medidata CTMS 2014.4.0. Vault eTMF customers who use Medidata can now realize the real-time TMF completeness and operational efficiency benefits of a productized integration between CTMS and eTMF.

This initial phase of the integration provides the following capabilities:

• When studies, study countries, and study sites are created in Medidata CTMS, they are also created in Vault eTMF — reducing the burden of manual data entry and helping ensure data consistency across the two systems.
• New auto-generation of Vault “Master File” binders for studies, study countries, and study sites ensures that as soon as the trial exists in the system, its binder also exists. This binder will serve as the central point where all trial documentation resides.
• Approving a monitoring visit report (MVR) in Medidata CTMS triggers the creation of the report in Vault eTMF as an approved document. The MVR is automatically filed into its appropriate place in the TMF.

The integration is fully productized, meaning that it will continue to be supported by Medidata and Veeva through future releases — sharply reducing the time and effort required for custom system integration. We’re excited to pass these benefits on to mutual customers of Medidata and Veeva, and to add more capability to the integration in future releases. Contact your Veeva representative today for a demonstration or to get the integration set up in Vault eTMF!

Todd Tullis is senior product manager at Veeva.