Enterprise-grade security and compliance you can trust
We maintain real-time monitoring across our security, privacy and infrastructure controls, ensuring ongoing compliance with global regulatory requirements.
Independently audited security controls ensuring data protection and privacy
Full compliance with healthcare data privacy and security regulations
International standard for information security management systems
End-to-end encryption for all data in transit and at rest
Multi-factor authentication (MFA) required for all users
Role-based access control (RBAC) with granular permissions
Regular third-party security audits and penetration testing
24/7 security monitoring and incident response
Automated data backup and disaster recovery procedures
Comprehensive audit logs and activity tracking
FHIR-compliant secure EHR integrations
At Kitsa, security and compliance are not afterthoughts. They are fundamental to everything we build. We understand that you're entrusting us with sensitive clinical trial data, and we take that responsibility seriously.
Our security program is continuously monitored, independently audited, and designed to exceed industry standards. We maintain certifications and compliance with the most stringent healthcare and data protection regulations, ensuring your data is protected at every level.
AI-assisted protocol, CSR, ICF, and SAP authoring with regulatory rigor.
Read moreHIPAA-compliant FHIR-based eligibility screening.
Read moreHow Kitsa handles personal and protected health information.
Read moreTalk to our team about regulated deployment.
Read moreFAQ
Keep exploring
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Discover the architectural patterns, validation frameworks, and compliance controls that make AI deployable in FDA- and EMA-regulated clinical research environments.
Learn how to build HIPAA-compliant AI infrastructure for clinical trials: BAA requirements, 21 CFR Part 11 validation, data governance, and audit trail best practices.
A Principal Investigator (PI) is the qualified physician or other appropriately credentialed professional who has primary responsibility for the conduct of a clinical trial at an investigational site, including protocol adherence, participant safety, data integrity, and regulatory compliance.