Tell Vivo what to watch, across every source.
Monitor data continuously across every connected source and alert when trends move in the wrong direction.
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.
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
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
Flag any subject whose dosing record disagrees with the IRT dispensation log by more than one kit.
↓
Executable rule + affected-entity preview · reviewed by data management · locked · scheduled on every refresh
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
Your risk register, mapped to live signals.
Risk oversight 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
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) →
Unlock AI-native RBQM. No coding required.
Continuous monitoring across every connected source, with signals turned into governed action.
