Tell Vivo what to watch, across every source.

Monitor data continuously across every connected source and alert when trends move in the wrong direction. AI-native RBQM with no coding required — and every signal connected to governed, auditable action.

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How It Works

A signal is only valuable if the right team acts on it.

Vivo continuously monitors trial data and turns signals into governed action — detect, alert, act, with the evidence preserved at every step.

Detect

Continuously watch for missing, late, inconsistent, unexpected, or high-risk patterns across all connected sources.

Alert

Generate governed alerts with source evidence and affected entities. Share across the team. Set thresholds from protocols or Ask Vivo prompts.

Act

Convert alerts to issues. Assign ownership. Track resolution. Preserve evidence packages for audit, inspection, and review.

Vivo monitors for risk across:

Missing or delayed data

Cross-system discrepancies

Enrollment & screen failure trends

Site & vendor performance drift

Visit adherence & retention risk

Protocol deviations

Safety & medical review signals

Endpoint readiness

Lock-readiness blockers

Issue Detection & Management

Identify the data issues you didn't anticipate.

Data discrepancies are detected automatically, with built-in issue management to carry each one from detection through resolution. And when your team spots a new pattern worth watching, the rule is written in plain language — Vivo generates the executable check, which is reviewable and lockable before it ever runs.

Discrepancy rules written in plain language, generated as executable checks
Every rule reviewable and lockable before it runs — human-governed automation
Rules are reusable across studies on the same foundation
Detection → query → resolution → evidence, tracked end to end

Rule Authoring

You write, in plain language

"Flag any subject whose dosing record disagrees with the IRT dispensation log by more than one kit."

↓

Vivo generates the check

Executable rule + affected-entity preview · reviewed by data management · locked · scheduled on every refresh

3 subjects flagged on first run → issues opened, assigned, and tracked with evidence preserved

The Risk Register

Your risk register, mapped to live signals.

RBQM in Vivo starts where quality teams already work: a register of risks. Each risk maps to monitored signals with thresholds your team sets. Breaches are counted as they happen, become issues with owners, and feed analytics that show where risk is concentrating.

Risks, signals, thresholds, and breach status in one register
Breaches open issues and tasks — owned, tracked, and preserved with evidence
Register analytics: where risk concentrates by site, category, and time
Structured to align with TransCelerate's risk-based quality management framework

OmniScience is a TransCelerate BioPharma Solution Collaboration Forum member ↗

Risk Register — Live

Visit non-compliance Breached · Site 211

Signal: out-of-window visits > 10% · issue opened, assigned to CRA

AE under-reporting Approaching threshold

Signal: AE rate per subject-visit vs. study mean · 2 sites trending low

Enrollment shortfall Within threshold

Signal: screening rate vs. plan · evaluated on every refresh

Signals evaluated continuously · breaches preserved with evidence

Risk-Based Quality Management

Built for the direction ICH E6(R3) is taking oversight.

Risk-based oversight assumes you can actually see risk as it develops. Vivo makes RBQM native: risks map to monitored signals, signals to alerts, alerts to issues and evidence — continuously, not at the next quarterly review. Read our take on ICH E6(R3) →