eTMF

Kivo eTMF is a cloud-based electronic Trial Master File system designed for clinical trial sponsors and CROs, with a focus on small pharma and clinical operations teams managing decentralized trials. It is built on the TMF Reference Model and covers the full lifecycle of a trial master file, from active trial management and site management through inspection readiness, migration, and long-term archival storage.

Kivo uses role-based, per-user pricing that includes access to the full platform — eTMF, RIM, and QMS — with no additional feature fees, platform fees, validation fees, support fees, or maintenance fees. The system is fully browser-based, requires no IT infrastructure, and is designed to be implemented within weeks rather than months.

Core eTMF Capabilities

• Active Trial Management: Built on the TMF Reference Model, the system provides advanced reporting and analytics to verify TMF completeness. Built-in workflows and process management tools are designed to enforce compliance across all contributors.
• Investigator Site Management: Supports selection and association of investigators with specific trials, automatically generating the correct tasks and document placeholders. Project management tools allow monitoring and reporting on document and task completion to keep study start-up on track.
• TMF Migration: Kivo provides a validated migration process from multiple TMF platforms, ingesting documents, metadata, and audit trails directly into the system. It also supports management of close-out documents that arrive after end-of-study transfer from a CRO.
• Inspection Readiness: Inspectors are granted secure accounts to view the eTMF, access document context, review content linked to partner systems or other records of record, and see complete document histories. Access can be configured in minutes, and the interface is designed to require minimal training for inspectors.
• Long-Term TMF Storage: Supports compliant, audit-ready archival storage for up to 25 years. The system provides functionality to transition a trial from active to closed status, apply updated permissions to restrict access while maintaining necessary visibility, and perform periodic data integrity checks and reporting to detect file corruption or compromise.

Platform Features

• Smart document placeholders aligned to the TMF Reference Model
• Drag-and-drop document upload
• Customizable authoring, review, QC, and approval workflows
• Collaboration features with customizable permissions
• Automatic audit trail
• Document linking with aliasing, eliminating the need for multi-indexing
• Intelligent analytics and reporting with customizable alerts
• Customizable metadata across features
• Integration with Microsoft Office Online
• Access to RIM, eCTD viewing, and QMS included within the same license, with no separate integration required

Security and Compliance

• CFR Part 11 compliant eSignatures integrated into the platform (DocuSign included)
• Single Sign-On (SSO) support
• Fully cloud-based with no IT setup required
• Available via browser on both PC and Mac
• Kivo undergoes a rigorous validation process to reduce the compliance burden on customer organizations

Regulatory Context

• FDA guidance for computerized systems states that electronically born documents must remain electronic throughout their lifecycle
• EMA requirements for clinical trial documentation specify a fit-for-purpose system in which all changes can be documented and traced
• Without a compliant eTMF system, sponsors cannot demonstrate an unbroken chain of custody, which creates inspection and audit risk
• TMF documents must be stored for up to 25 years depending on the region
• The TMF Reference Model organizes artifacts into 11 zones: Trial Management, Central Trial Documents, Regulatory, IRB/IEC and Other Approvals, Site Management, Investigational Product and Trial Supplies, Safety Reporting, Centralized and Local Testing, Third Parties, Data Management, and Statistics

Implementation and Support

• Implementation is designed to be completed within weeks
• Unlimited live training is provided for the duration of the customer relationship, including when new team members are onboarded
• Human support is available five days a week from 6am to 6pm PST, with a stated response time of under five minutes during business hours
• Unlimited support is included with no additional support fees

Kivo eTMF is positioned as a more cost-effective alternative to storing TMF documents within a CRO's system, particularly for long-term storage, as it does not charge per gigabyte or per study. The platform is designed to address the compliance gaps common when teams rely on tools such as SharePoint or general cloud file storage during early trial phases.