Clinical AI must be explainable, permission-aware, and reviewable.
Powerful AI is not enough for clinical trials.
Clinical trial data is among the most regulated and consequential data on the planet. It informs regulatory submissions, product safety decisions, and patient care. The AI layer over that data carries the same burden. Vivo is designed for this standard.
Built for clinical-grade data handling.
Vivo handles de-identified and identified clinical trial data in compliance with HIPAA and GDPR. Data residency, access controls, encryption at rest and in transit, and audit logging are standard, not optional.
HIPAA compliance for protected health information
GDPR compliance for EU/EEA subject data
Encryption at rest and in transit (TLS 1.2+, AES-256)
Data residency controls for global trials
Penetration testing and vulnerability management
Single sign-on (SSO) and MFA enforcement
LLM providers forbidden from model training on customer data
Aligned with the standards that govern clinical AI.
GxP Validation Framework
Risk-based validation approach aligned with intended use. GMP, GCP, and GDP-aligned quality system.
ISO 9001
Quality Management System (QMS) certification covering product development and delivery.
ISO 27001
Information Security Management System (ISMS) certification covering organizational data protection and risk controls.
Role-based and blinding-aware — enforced at the data layer.
Every user interacts with a Vivo that reflects their role, function, and study assignment. A medical monitor sees different data than a data manager. A sponsor sees different data than a CRO site coordinator. And in active trials, blinding integrity is enforced at the platform level — not just in the UI.
Role-based access control (RBAC) — configurable per study and organization
Blinding-aware data access — treatment arm, dose group, and endpoint data protected
Ask Vivo answers are role-aware — the AI cannot return data the user should not see
Sponsor, CRO, and site access scoped independently
Access logs, session records, and permission changes audited
Medical Monitor
Full safety data view · AEs, labs, SAEs, dose · Blinding-aware · Evidence packages
Data Manager
EDC, labs, queries, review state, completeness · No treatment arm data
ClinOps / Study Lead
Enrollment, sites, vendors, operational status · Trial Home · Protocol adherence
Portfolio Leader
Cross-study risk view · Portfolio Ask Vivo · Executive reporting scope
Source-Backed Answers & Audit Trails
Every Vivo answer, alert, and insight links back to the specific source records, transformation steps, and protocol context that support it. You can trace from conclusion to evidence in two clicks. Every answer, query, and workflow action is timestamped, attributed, and preserved.
Human Review & Governed Automation
AI in Vivo assists clinical teams — it does not replace them. Alerts, issues, and monitoring outputs are reviewed by humans before action. Governed workflows include reviewer comments, decision attribution, resolution records, and complete audit trails. AI signals the risk. People own the response.
Exploratory vs. Confirmatory Workflows
Vivo draws a clear distinction between exploratory and confirmatory use. Ask Vivo is designed for operational insight and monitoring — not for pre-specified statistical analysis or hypothesis confirmation. Clinical AI should accelerate insight without weakening scientific discipline.
Exploratory use (operational) and confirmatory use (statistical analysis) are governed separately.
Prompt & Usage Monitoring
Governed AI includes governing how AI is used. Vivo monitors usage patterns across studies for anomalous queries, blinding-adjacent questions, cross-arm comparisons in active trials, and usage that may affect study integrity. This is a proactive safety layer, not just an audit log.
Validation is not one-size-fits-all. It should follow intended use.
Vivo supports sponsor validation programs with documentation, risk assessments, testing artifacts, and implementation guides aligned with FDA CSA guidance and GxP quality frameworks.
What OmniScience Provides
Quality Management System (ISO 9001)
Change control and release management
Risk-based validation documentation
System description and IQ/OQ/PQ support materials
Audit trail and electronic record documentation
Vendor qualification support package
What Sponsor Teams Do
Sponsor validation protocol and report
Risk and intended use classification
User acceptance testing (UAT)
Internal SOP alignment and training records
Study-specific configuration documentation
Periodic review and requalification
Ready for every stakeholder in the evaluation process.
IT & Security Teams
SSO / SAML / SCIM integration
MFA enforcement
Data residency options
Penetration test artifacts
Vendor security questionnaire support
QA & Compliance Teams
Vendor qualification package
Validation support documentation
QMS overview (ISO 9001)
Change control and release notes
On-site audit support
Enterprise AI / Innovation Teams
API documentation and sandbox access
LLM provider and model governance details
AI evaluation methodology
Data handling and model training restrictions
Agent interoperability and API contracts
Ready for a vendor assessment?
Our team provides detailed documentation, qualification materials, and questionnaire support.
