Implement Within a Week
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.
Migrate within Weeks, Not Months
Kivo has built a validated migration process from many TMF platforms to ingest documents, metadata, and audit trails directly into Kivo. A direct connection to your CRO's SFTP or system, there are no gaps in compliance or audit trail by relying on uncontrolled devices or transfers. Manage close out documents that arrive after end of study transfer from your CRO and have visibility into overall TMF completion with intelligent flexible reporting. You can even automate reports to be delivered straight to your inbox.
Features:
- Smart Document Placeholders built to align to the TMF reference model
- Intelligent, automated reporting to track TMF completeness
- Fully validated, with no validation fee
- Secure data transfer
- Customizable permissions for 3rd Party Access, Contributors, and Read Only users
- Supports Unblinded Data
- Preserves metadata and audit trails to maintain compliance with FDA and EMA regulations
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Control Inspector Access
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.
Features:
- Unique user role for Inspectors
- Limit inspector access to approved documents
- Metadata and audit trails functionality reduces risk of missing or incomplete TMFs
- Identify documents available in other systems of record
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Keep Long-Term TMF Storage Costs Low
Your TMF must be stored for decades, accessible for inspectors at any time. 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. Our cloud-based solution ensures data is always easily accessible without IT involvement or maintaining your own infrastructure.
TMF Storage Features:
- No per GB charge
- Subscription based pricing for a fraction of the cost of storing studies with your CRO or other eTMF vendors
- Read only access available
- Automated quarterly data checks to ensure file integrity
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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
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!)