Special Delivery – Vault eTMF Document Packages for Faster Site Start-up
Site start-up is one of the most hectic periods in clinical trials due to the sheer volume of work involved and the pressure to get sites initiated quickly. Simplifying communication with sites can greatly reduce the strain associated with this critical phase. The latest release of Veeva Vault eTMF contains a new feature called “document packages” that helps identify the relevant documents and deliver them to sites, speeding up site activation and returning valuable time to trial managers.
The frenzy around site initiation is fed by the variation in site requirements, particularly in local IRB/IEC submissions and approvals. Each IRB/IEC may have different requirements for documents such as proof of insurance or import licenses, making it easy to forget important study or country-level documents. Omitting one of these documents could lead to missing an IRB/IEC submission deadline – a huge setback.
Vault eTMF’s document packages will help manage and track these complicated communications. Relevant documents are presented to the trial team, organized by study, country, and site level. Displaying the necessary documents in one location reduces the chance of someone inadvertently forgetting to send or request an article from a site. The user selects the documents that must be requested from or completed by the site. The application then automatically adds in the right recipients based on pre-defined workflows. Fill in due dates, click “send,” and your electronic site initiation document package is on its way! When amendments, or other changes occur, simply repeat the process by selecting the new documents to send or request from the site.
Sites often get requests and documents one at a time. The information is rarely consolidated in one place. With Vault’s document packages, site personnel receive an organized list of tasks and related documents within the Vault Investigator Portal. Sites can easily track their deliverables in the Portal, checking off completed items.
The document packages feature enhances Vault eTMF and was designed and developed in just eight weeks, making it a great example of the rapid innovation you get with multitenant cloud. To see even more ways Vault eTMF can expedite study start-up — including streamlined collection, review, and approval processes — watch our demo here.
Todd Tullis is senior product manager, Veeva Vault eTMF.