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, not just described as compliant with it.
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.
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-Aware Access Example
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.
"Trust does not come from confidence. Trust comes from traceability."
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.
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.
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.
Vivo supports sponsor validation programs with documentation, risk assessments, testing artifacts, and implementation guides aligned with FDA CSA guidance and GxP quality frameworks.
Our team provides detailed documentation, qualification materials, and questionnaire support.