Kivo
Kivo is building the infrastructure for GxP compliance in the era of AI-powered drug development. Its unified cloud platform supports Regulatory, Clinical, and Quality operations — including RIM, eTMF, QMS, controlled document management, submission assembly, eCTD lifecycle management, inspection readiness, SOP management, and training management — within a single, audit-ready environment. With Part 11-compliant e-signatures, role-based permissions, continuous validation assurance, and a lossless data model that preserves context from legacy systems, Kivo gives life sciences teams the compliant foundation to reduce operational friction and accelerate time to market. ▶ For Regulatory • Customizable, automatic authoring, review, QC, and approval workflows • Real-time collaboration online or locally in Office 365 • Smart document placeholders, with pre-formatted ICH templates available • Assemble submissions from pre-built submission structures aligned to country guidelines • Create automated tracking spreadsheets for external publishing groups ▶ For Quality • Controlled document and SOP management that meets GxP standards • Training management linked directly to documents in the DMS • Build curricula for teams or individual users with documents, videos, and quizzes • Auto-fill quality forms with metadata • Manage change controls, CAPAs, Deviations, Audits, and Vendors ▶ For Clinical • Workflows mapped to the TMF reference model • Accelerate active trial management, from study start up and beyond • Migrate TMFs into the system in weeks, including recompiled audit trails • Real-time reporting into TMF completeness • Long-term TMF storage at a fraction of the typical cost, with automatic checksums to ensure data integrity • Separate inspector access to help streamline your trial narrative
Average Rating: 4.9/5.0
Total Reviews: 23
How Do G2 Users Rate Kivo?
- Has the product been a good partner in doing business?: 10.0/10 (Category avg: 9.2/10)
- Quality Processes: 10.0/10 (Category avg: 9.0/10)
- Audit Management: 10.0/10 (Category avg: 8.7/10)
Who Is the Company Behind Kivo?
- Seller: Kivo
- Company Website:
- Year Founded: 2021
- HQ Location: Portland, US
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LinkedIn® Page: www.linkedin.com
47 employees on LinkedIn®
Who Uses This Product?
- Top Industries: Biotechnology, Pharmaceuticals
- Company Size: 65% Small, 35% Medium
What Do G2 Reviewers Say About Kivo?
AI-generated summary from verified user reviews
Pros
- Users appreciate the ease of use of Kivo, highlighting its intuitive design and minimal learning curve.
- Users praise the implementation ease of Kivo, highlighting its intuitive design and efficient onboarding process.
- Users appreciate Kivo's intuitive user interface, enabling easy navigation and minimal learning curve for new users.
- Users praise Kivo for its excellent customer support, highlighting responsiveness, professionalism, and effective assistance throughout implementation.
- Users value Kivo's customization options, enabling tailored solutions that meet specific organizational needs effectively.
Cons
- Users find feature limitations in Kivo, needing workarounds for incomplete functionalities like electronic signatures.
- Users express concern over missing features, particularly with electronic signatures needing workarounds for functionality.
- Users find the left-side navigation confusing, which detracts from their overall experience with Kivo.
What Are Recent G2 Reviews of Kivo?
"Responsive, Customer-Focused RIM Platform That’s Simple, Scalable, and Flexible"
Rating: 5.0/5.0 stars
— Natalya S.
"Intuitive, Well-Supported QMS with Fast Responses and Powerful Platform"
Rating: 5.0/5.0 stars
— Bill W.

