Kivo

Kivo is a document and process management platform designed for life sciences teams, specifically pharmaceutical sponsors and contract research organizations (CROs). The platform provides a unified, compliant workspace covering Regulatory Information Management (RIM), electronic Trial Master File (eTMF), Quality Management System (QMS), and Document Management System (DMS) functions. Kivo rebranded under its current name in 2021 after a decade of working with R&D operations teams, and has since served more than 100 sponsor and service provider organizations. The platform is positioned as an affordable alternative to both informal tools such as SharePoint and legacy enterprise compliance systems, with pricing starting at $1,800 per month and an all-inclusive model that covers setup, support, and lifetime system validation.

Kivo serves scaling pharmaceutical and life sciences teams — including small, venture- and private equity-backed sponsors that make up a growing share of active drug trials — as well as service partners such as CROs. The platform is 21 CFR Part 11 compliant, validated on day one, and is designed to keep teams audit- and diligence-ready at all times. Kivo reports being rated the number one and easiest-to-use RIM solution in G2 reviews, with more than 100 regulatory applications and 60 or more clinical trials managed on the platform.

Document Management System (DMS)

• Controlled document management with 21 CFR Part 11 compliant electronic signatures, with DocuSign included
• Management of controlled documents and corporate documents
• Process automation capabilities
• Project management tools
• Diligence readiness support

Regulatory Information Management (RIM)

• Supports authoring, publishing handoff, and lifecycle management of regulatory content
• Submission assembly tools
• Project and dossier management
• Correspondence and commitments tracking
• eCTD viewing
• ICH document templates

Electronic Trial Master File (eTMF)

• Covers the full trial lifecycle including migration, active trial management, inspection readiness, and long-term storage
• Site management functionality
• End of study TMF transfer support
• Long-term TMF storage

Quality Management System (QMS)

• Oversight of internal and external parties including vendors
• SOPs and document management
• Quality events tracking
• Vendor audit management
• Training management

Platform Characteristics and Deployment

• Single unified workspace shared across Regulatory, Clinical, and Quality functions
• 100% CFR Part 11 compliant; validated on day one of deployment
• All-inclusive pricing covers setup, ongoing support, and lifetime system validation
• Pricing designed to accommodate teams ranging from 5 to 500 users, starting at $1,800 per month
• Setup measured in days rather than months
• Designed to replace patchwork tools such as SharePoint or outdated legacy RIM, eTMF, and QMS systems

Company Background and Scale

• More than 100 life sciences teams rely on Kivo across sponsor and service provider organizations
• More than 100 regulatory applications managed on the platform
• More than 60 clinical trials running on Kivo, either active or in long-term storage
• The team brings over 100 combined years of regulatory and clinical expertise
• Kivo partners with a variety of organizations across the life sciences industry
• Resources available include whitepapers, case studies, webinars, demos, and articles

Kivo is headquartered and reachable via [email protected] and (503) 583-2471. The platform is intended for life sciences teams that need a compliant, connected workspace without the cost and implementation timelines associated with traditional enterprise solutions.