KIVO ETMF
Flexible eTMF Solutions for Sponsors and CROs
Accelerate clinical trials and streamline TMF management with Kivo’s fully compliant, cloud-based eTMF System.
A Fit-for-Purpose eTMF
that works like you
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.
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.
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.
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.
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.
Support from Day 1
Implement Within Weeks
Kivo goes through a rigorous validation process to reduce the burden on your organization and shorten implementation timelines — no long, drawn-out rollouts.
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.
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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!)