Product Overview
Accelerate clinical trials and streamline TMF management with Kivo’s fully compliant, cloud-based eTMF System
Managing a clinical trial can be a challenge, but with the right tools, you can make managing active trials much simpler. Kivo’s eTMF is built on the TMF reference model. With advanced reporting and analytics, you can verify your TMF completeness at a glance. And with built in workflows and process management tools designed to follow all relevant regulations, you can enforce compliance across all your contributors.
- Built on TMF Reference Model
- Role-Based, Per User Licensing for Full Platform, Limited Access, and 3rd-Party Access
- Smart Document Placeholders
- Drag and Drop Document Upload
- Customizable Authoring, Review, QC, and Approval Workflows
- Collaboration Features with Customizable Permissions
- Automatic Audit Trail
Deployment
- Web based
- Cloud Hosted
Pricing
- Subscription
- License Fee
More Information
Unapologetically Simple Pricing
All the eTMF functionality you need at an unbeatable price.
Kivo uses straightforward, role-based user pricing for sponsors, CROs, and Inspectors. Your license grants you access to every feature - eTMF, RIM, and more - for no additional cost. You will never be charged a feature fee, platform fee, validation fee, support fee, or maintenance fee. Ever.
So why do you actually need an eTMF System?
In the early stages of a clinical trial, it's common to be using SharePoint, your CRO's eTMF, and a handful of cloud-based file storage systems to keep track of your trial. But as trials move to later phases, the number of documents can quickly get out of hand. These bandaid solutions are not designed to manage clinical operations, and they are most certainly not compliant.
FDA Guidance for Computerized Systems states “if it was born electronic it needs to stay electronic.” Similarly, EMA “clinical trials documentation requires a “Fit for purpose system” where all changes can be documented and traced.
Without an electronic trial master file system, you won’t be able to demonstrate an unbroken chain of custody - opening your study up to inspection and audit risk. You’ve likely spent millions on your study - don’t leave the hard work of all the contributors and patients vulnerable to this easily preventable issue.
About the company
We’re a team of regulatory experts and software architects who came together to create a better document collaboration solution for today’s emerging life science teams.
Starting in 2012 with our original ‘Gemstone’ platform, we’ve been building our expertise working with fast-growing life sciences teams – and realized that these teams need a solution built specifically for their size, scale, and distributed way of working.