Compliance without the complexity.
DMS | RIM | QMS | eTMF | Headless GxPTM
Kivo is the compliance platform for clinical-stage biotech teams and the partners that support them, from pre-IND through approval.
Powering Innovative Sponsors & Service Partners Worldwide
DON't take our word for it
Recent Reviews — Kivo leads on G2 with 4.9/5 stars
Tara G
CEO & Principal Consultant
"Kivo is a QMS & RIMs game changer. It competes strongly against its Goliath peers. From onboarding to troubleshooting, their team has been a reliable partner at every step."
Marissa B.
Senior Manager, Regulatory Affairs
"I have been using Kivo daily for over 2 years to manage 15+ drug development programs. It was extremely easy to learn and very intuitive for a regulatory affairs professional. Kivo makes the process incredibly easy."
Seppe G.
Director of Regulatory Affairs and Quality Assurance
"The intuitive on-line interface has been adapted quickly by the entire development team allowing both the CMC experts as well as the clinical team to seamlessly integrate internal documents as well as controlled documents from external parties."
Kristi N.
VP of Regulatory Affairs
"Kivo was really fast to set up training, and then because the system is so user-friendly, it just didn’t take that much time to get people up to speed. Normally the learning curve with a system like this is quite steep, but Kivo is so intuitive we can quickly get people oriented and off to the races."
Brian A.
Senior Manager, Regulatory Affairs
"Kivo is extremely user friendly, which has allowed implementation of the RIM system seamlessly throughout our company. The Kivo team has been great in walking us through the various questions we have and implementing feedback to better enhance our experience."
Veronique V.
Quality Assurance Manager
"We're very happy to have all our documents stored in the same place. It's efficient to have a system where the review of a doc can be done simultaneously by several reviewers. The Kivo team is always ready to help and always listen to customer needs. Really appreciated."
Part 11 Compliant, Validated Document & Content Management System
- Collaborative editing & review with Microsoft Office desktop
- Use Kivo's built-in Part 11 compliant electronic signatures
- Automate and enforce workflows that match your SOPs
- Set access rights based on user roles/permissions
- Easily find docs & content with Full-Text Search
#1 Regulatory Management System for Life Sciences
- Complete RIM System for the entire submission lifecycle
- Real-time collaboration in Word
- Agency activity & correspondence tracking
- Prepare & deliver submissions for publishing (internal or external)
- View & manage submitted eCTDs
- Part-11 Compliant e-Signatures
- Customizable automated workflows
A Quality Foundation for Efficient Compliance
- SOP authoring & Part-11 approvals
- Training module with curriculum builder, auto-enrollment, quizzes
- Quality Events - incl. Deviations, CAPAs, Change Controls, etc.
- Vendor qualification, audits, events
- User permissions & document access by user role
- Flexible "Read-Only" Users for SOP Access, Training & e-signature
eTMF, TMF Migration, and Active Trial Management
- Sponsors & CROs use Kivo to manage study eTMFs & Trial Activities
- Efficient migration of completed studies - including Audit Trails & QC
- Compliant & affordable TMF long-term storage available
- Easy data migration both in and out of the system - no lock-in
- Always inspection-ready, including quarterly data integrity checks
- TMF completeness & QC reporting
Security & Trust
Security and data integrity is at the heart of what we do. We help our customers achieve compliance, and that starts with us.
Security & Architecture
- Single Sign On (SSO), Multi-Factor Authentication (MFA) Ready
- User Attack Vector Protection: Bot Detection, IP Throttling, Brute-force Protection, Breached Password Detection
- All data uses 256-bit encryption in transit and at rest
- Multi-continent data failover and auto-scaling
- Highly granular user permission model to control access including a secure document viewer that prevents downloading, printing, or copying text from documents
Validation Approach
- Qualification, testing, and validation approaches aligned with software and GCP best practices
- Complete OQ in a validation environment conducted prior to each release, screenshots provided
- UAT in production as part of each release that includes major process and performance considerations
- Validation package loaded into your Kivo workspace for each release
- SOP packages updated with each release
See what's possible with Kivo today.
"With all that Kivo has to offer, I can't imagine using anything else."
- Senior Manager, Regulatory Strategy
