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KIVO ETMF

Cost-Effective eTMF Solutions for Sponsors

Accelerate clinical trials and streamline TMF management with Kivo’s fully compliant, cloud-based eTMF System

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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.

A Fit-for-Purpose eTMF
that works like you

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Active Trial Management

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.

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Investigator Site Management

Choose the right investigator for each trial with Kivo. When you’ve made a decision, associate the Investigator with the appropriate trial to automatically create the correct tasks and placeholders for the necessary documentation. Finally, use our project management tools to monitor and report on document and task completion to keep study start-up on track. 

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TMF Migration Made Simple

Migrate your existing studies within weeks. Kivo has built a validated migration process from many TMF platforms to ingest documents, metadata, and audit trails directly into Kivo. Manage close out documents that arrive after end of study transfer from your CRO and have visibility into overall TMF completion.

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Reduce TMF Inspection Risk

Kivo was built from the ground up to support virtual inspections. Inspectors use a secure account to view the eTMF and gain context for documents, content that is accessible with partners or other systems of record, and complete document histories. Access can be granted and customized in minutes, and the system is so easy to use Inspectors can do their jobs with minimal training.

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Long Term TMF Storage

Your TMF could need to be archived and accessible for up to 25 years. TMF storage can be surprisingly expensive. But with Kivo, we offer fully compliant, audit-ready long-term storage for a fraction of the cost of any other provider. How? By providing functionality to seamlessly transition a trial from active to closed and apply new permissions to lock down security while still providing necessary access. Kivo offers a novel approach to periodic data integrity checks and reporting to ensure that files are not corrupted or compromised while in storage.

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.

Download our TMF Transfer Whitepaper for more information on regulatory guidance

Features that scale. Costs that don't.

Kivo eTMF
  • TMF Features
    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
  • Kivo GO Features
    Access to RIM, eCTD, & QMS Included (No Integration Required)
    Intelligent Analytics and Reporting with Customizable Alerts
    Document Linking with Aliasing (No Multi-Indexing Required)
    Seamless Integration with Microsoft Office Online
    Customizable Metadata Across Features
  • IT & Security
    Integrated CFR Part 11 Compliant eSignatures
    No IT Required (Fully Cloud Based)
    Single Sign On
    Fully Browser Based, Available for PC and Mac
  • Support
    Lightning Fast Support During Business Hours (Under 10 Minutes!)
    Unlimited Live Training
    Implement Within Weeks
    Unlimited Support

Support from Day 1

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Implement Within Weeks

Kivo goes through a rigorous validation process to reduce the burden on your organization and reduce implementation timelines. No more implementations that drag on for months - seriously.

Unlimited Training
Unlimited Training

Receive unlimited training as long as you are a customer. We want to make sure your team is comfortable and able to get work done, so we’ll be there to help every step of the way, even when you bring on new team members.

Real Human Support (1)
Real Human Support

Support is available from a real human being 5 days a week from 6am to 6pm PST. Our current response time during those hours is under 5 minutes (really!)

Protect your Study without Breaking 
the Bank

Get Kivo eTMF today