Vivo delivers value across workflows, functions, and studies.
Most study teams manage trial oversight the same way: collect updates from EDC, CTMS, CRO reports, vendor portals, and spreadsheets every week. Reconcile them manually. Build a status slide. Share it 3 days later. By then, something has changed.
Vivo replaces this cycle with a continuously updated operating picture.
Why current approaches fall short:
How Vivo helps:
Ask Vivo — Trial Oversight
"We can now ask questions that used to take a week to answer — in seconds, with the source data attached."
Data Quality Workflow
Data quality issues often live between systems. EDC checks catch intra-system errors. But cross-system discrepancies — between labs and EDC, between safety database and EDC, between imaging and EDC — remain invisible until someone manually reconciles exports.
Vivo unifies data across sources and continuously monitors for patterns that matter: missing data, cross-system inconsistencies, records that changed after review, visit completeness gaps, and lock-readiness blockers.
How Vivo helps:
Enrollment delays are the most common source of trial timeline risk — and the most preventable. Screen failure rates, site activation lag, protocol criterion barriers, retention dropout patterns, and site-level underperformance are often visible in the data weeks before they surface in a status report.
Vivo connects enrollment, screening, randomization, visit adherence, dropout, IRT, CTMS, and site data into an early-warning picture — surfaced through Ask Vivo questions, alerts, and continuous monitoring.
Vivo helps teams understand:
Enrollment Intelligence — Ask Vivo
Safety Context — Subject Level
Safety signals need clinical context to be actionable. An AE is more meaningful when you can immediately see the subject's dose history, concomitant medications, labs, prior AEs, and protocol context — not just the event record in isolation.
Vivo gives safety and medical monitoring teams subject-level context for signals, site- and cohort-level aggregation to detect patterns, and source-backed evidence packages for review meetings, DSMB preparation, and safety reporting.
Key capabilities:
"Vivo is our new best friend."
Medical Monitor · Phase 2 Rare Disease TrialClinical development leaders rarely lack information. They lack the right information, organized for the right decision, at the right time. Vivo gives portfolio and development leadership a shared operating picture across studies that is continuously updated, drill-able, and source-backed.
Rather than waiting for each study team to assemble and share a periodic update, leaders can see portfolio risk, performance, and change in near real-time — and ask questions across studies.
Portfolio Ask Vivo examples:
Portfolio Visibility
The FDA's new operating models and evolving inspection expectations call for evidence-backed documentation of what happened, when it happened, who acted, and what changed. Vivo is designed for this operating model from the ground up.
AI-RBQM monitors for risk continuously — not at periodic review cycles. Signals, alerts, issues, and evidence packages are preserved as they happen.
Every answer, alert, and issue links back to the underlying source records with provenance and transformation history — inspection-ready evidence on demand.
All workflows include reviewer comments, decision records, timestamps, and attribution. AI assists — humans decide and sign.
Purpose-built for FDA Computer System Assurance guidance. Supports decentralized, hybrid, and traditional trial designs.
"Clinical AI should accelerate insight without weakening scientific discipline."
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