Source-backed safety oversight in clinical context.

Safety and medical monitoring teams need to see AE, lab, dose, conmed, subject, site, cohort, and protocol patterns together. Vivo surfaces safety and medical review signals in context so teams can investigate earlier with evidence.

The Challenge

Where teams get stuck today.

  • AEs, labs, conmeds, dose records, and safety system data live in separate places
  • Identifying whether a signal is site-specific, cohort-driven, or study-wide requires manual analysis
  • Special interest event monitoring is periodic rather than continuous
  • Safety review meeting preparation requires manual evidence assembly across exports and listings
  • Blinding and role controls may not be enforced when ad-hoc queries cross arms or endpoints
How Vivo Helps

What Vivo makes possible.

  • Subject-level safety context: AEs, SAEs, special interest events, labs, conmeds, dose, medical history
  • AE / lab / conmed / dose relationship investigation with source-backed evidence
  • Continuous monitoring for special interest events and protocol-defined safety thresholds
  • Site- and cohort-level signal review — isolate or rule out systemic patterns
  • Blinding-aware access controls appropriate for active trial environments
  • Evidence packages with source records, protocol context, reviewer comments, and audit trail
Ask Vivo — Example Questions

The questions Safety & Medical Monitoring teams ask Vivo every day.

Ask Vivo

Which subjects had abnormal labs in the last 4 weeks?
Are any adverse events clustered by site, cohort, dose, or timing?
For AEs related to drug dose, what are the most common concomitant medications?
Are any special interest events increasing over time?
What source records support this safety signal?

"Vivo is our new best friend."

Medical Monitor · Phase 2 Rare Disease Trial

Investigate safety signals earlier, with the context to act.

See how Vivo helps safety & medical monitoring teams with live trial data, source-backed AI, and governed workflows.