Considerations for moving an electronic clinical trial
Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a...
Last week we announced our new eTMF product. While that launch has stole the headlines and attention, the Kivo team has been hard at work over the fast few months rolling out a significant number of new features and enhancements across the product line. Here's a round up of some of the newer features that you may have missed.
Previously Kivo supported opening documents in Office 365 for editing or collaboration. Users can now choose to open documents in Word Desktop.
Kivo supports cabinet types, and the app can have multiple document areas and navigation for Regulatory, eTMF, Quality, and Corporate documents.
Customers can customize session inactivity timeouts to align to their internal IT standards. The default timeout is 15 minutes, but this can be adjusted to be longer or shorter.
The system can capture a reason for deletion on versions, documents, folders, and cabinets.
Kivo now has an eCTD Viewer to enable you to view eCTD submissions right in the application. The eCTD Viewer supports associating documents in an eCTD to their corresponding version in the DMS so that you always know which versions of a document have been submitted to a regulatory agency.
Submission Builder has templates for submissions. Current templates include IND, NDA, BLA, and DSUR with more being added.
This is largely a support-focused feature, but it enables Kivo to import and export submission and folder structures between organizations. This is helpful to re-use submission structures or to upload custom cabinet structures for areas like Quality.
Kivo has full support for managing an eTMF directly in the application.
Kivo supports the entire v3.2.1 eTMF reference model including automatic study, site, vendor, and meeting section creation.
Document Aliases enable you to have a file display in multiple folders in the DMS. This is helpful for documents, like a clinical protocol, that may be authored in one location but need to appear inside your eTMF cabinet for a study. Aliases can be created linking to a specific version, all versions of a document, or only display approved versions. These options are especially helpful when linking documents like a Protocol to an eTMF to ensure that sites only have access to approved versions of a document.
Kivo now supports a new class of user for Audits, Inspections, Due Diligence, or other scenarios where you need to significantly restrict access to data.
Moving an electronic Trial Master File (eTMF) can be a complex process that requires careful planning, coordination, and execution. A TMF is a...
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