Where teams start.
Where they go next.
Vivo delivers value across workflows, functions, and studies.
Trial Oversight
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:
Data is current in individual systems but stale by the time it's assembled and shared
Risk detection relies on people noticing problems in exports, not the systems alerting them
Meeting preparation consumes hours that should be spent on execution
There is no consistent definition of "study status" across functions
How Vivo helps:
Trial Home shows what changed, what needs attention, and what actions are pending — continuously
Unified enrollment, site, vendor, protocol, safety, and data quality status in one view
Ask Vivo answers pre-meeting questions in seconds: "What changed since last week?"
Trial News summaries keep cross-functional teams aligned without manual reporting
Alerts, issue ownership, and follow-up tracked from one operating surface
What changed in trial status since the last study team meeting?
Are there any sites below 70% of enrollment plan right now?
Which vendors have outstanding deliverables this week?
What protocol deviations were logged in the past 30 days?
"We can now ask questions that used to take a week to answer — in seconds, with the source data attached."
Data Quality & Readiness
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:
Cross-system discrepancy detection — EDC vs. labs, safety, imaging, eCOA, IRT, vendor files
Completeness, missingness, and visit adherence monitoring by domain and subject
Changed-since-review detection — catch what moved after a prior review cycle closed
Source provenance, mapping history, and transformation transparency visible in product
Detect
Cross-system discrepancies, missingness, review-state gaps surfaced automatically
Triage
Prioritize by domain, subject, site, endpoint criticality, and milestone impact
Query / Resolve
Issue queries, assign ownership, track status, follow up across vendors and CROs
Re-review
Changed-since-review detection — see exactly what changed after prior sign-off
Prove Readiness
Lock-readiness evidence bundles with source records, provenance, and review history
Enrollment & Retention
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:
Which sites are below enrollment plan — and by how much, and for how long
Which inclusion/exclusion criteria are driving the most screen failures
Whether retention dropout is isolated to specific sites, cohorts, or visits
Which site activations are lagging and creating pipeline risk
Enrollment trajectory vs. plan across countries, regions, and time
Which IE criteria are driving the most screen failures across all sites?
IE-03 (prior CNS medication exclusion) accounts for 38% of all screen failures. IE-07 (MMSE threshold) accounts for 22%. Both are site 104 and site 211 patterns. Site 104 has not adjusted its pre-screening approach since activation.
Safety Review
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:
Subject-level safety context: AEs, labs, conmeds, dose, MedHx, visit adherence
Site, cohort, and dose-level signal aggregation and comparison
Special interest event monitoring with protocol-defined thresholds
Blinding-aware access controls for active trial environments
Evidence packages for review meetings, DSMBs, and safety reports
AE Cluster Signal
Injection-site reactions 3.2× higher at Site 104 vs. study mean. All 7 cases in Cohort B (high dose). No clustering in Cohorts A or C.
Lab Context
3 of 7 subjects show elevated CRP and ESR. No dose holds or protocol deviations recorded at Site 104 for these subjects.
Evidence Package Ready
Source records, protocol context, MedDRA coding, reviewer comments assembled for medical monitor review.
"Vivo is our new best friend."
Portfolio Intelligence
Clinical 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:
Which studies have the highest execution risk this month?
Which sites have reported the most protocol deviations across phases for an asset?
What changed across the portfolio since last week's review?
Which milestones are under pressure in Q3?
Study OS-204 · Oncology
Enrollment −18% · 2 site activations overdue · Vendor data lag
Study CNS-107 · Alzheimer's
Protocol deviation rate +22% over 4 weeks · Site 211 flagged
Study IMM-033 · I&I Phase 3
Enrollment on plan · Data quality clean · No open alerts
Study RD-019 · Rare Disease
Lock readiness progressing · 2 open DM queries
Real-Time Trial Readiness
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.
Continuous Oversight
AI-RBQM monitors for risk continuously — not at periodic review cycles. Signals, alerts, issues, and evidence packages are preserved as they happen.
Source-Backed Evidence
Every answer, alert, and issue links back to the underlying source records with provenance and transformation history — inspection-ready evidence on demand.
Human Review & Audit Trails
All workflows include reviewer comments, decision records, timestamps, and attribution. AI assists — humans decide and sign.
FDA CSA & Decentralized Trial Ready
Purpose-built for FDA Computer System Assurance guidance. Supports decentralized, hybrid, and traditional trial designs.
Clinical AI should accelerate insight while maintaining rigorous quality.
Explore Trust & Compliance →Site Selection & Feasibility
Feasibility teams assemble site shortlists from spreadsheets of past performance, self-reported questionnaires, and subscription databases that don’t know your own history. The sites that burned you last time look identical to the ones that delivered.
Vivo plans the next trial on mastered site intelligence instead.
Why current approaches fall short:
Your own trial history lives in old CTMS records and closed-out study folders
The same site and investigator appear under different names across sources
Feasibility questionnaires are self-reported and rarely reconciled against actuals
Competing-trial pressure at a site is invisible until enrollment stalls
How Vivo helps:
One golden record per site and investigator — internal, public, and subscribed sources reconciled
Compare a site’s performance for you vs. everyone else
Enrollment scenarios grounded in site-level history, not portfolio averages
Plans made here give the running trial a warm start in Trial Oversight
Have any of the sites I’m considering struggled with recruitment historically?
In our last trial, could we have predicted that Site X would enroll zero patients?
Who is running a competing trial, and what sites are they using?
Of our historic trials in immunology, which sites were slowest to start up?
DSMB & Safety Committee Preparation
Every DSMB cycle, someone senior spends days pulling listings, rebuilding tables, and reconciling versions across EDC exports, safety-database extracts, and statistics outputs — then does it all again next quarter.
Vivo assembles committee-ready evidence from the live, traceable data the trial already runs on.
Why current approaches fall short:
Evidence assembly consumes senior clinical time better spent on the review itself
Tables are rebuilt by hand each cycle, so each cycle re-introduces version risk
Questions raised in the meeting take another data pull to answer
Between cycles, the safety picture goes unwatched by the committee process
How Vivo helps:
Safety overviews, participant profiles, and longitudinal views assembled from live data
Every figure traceable to its source records — evidence, not screenshots of exports
Follow-up questions answered in the meeting via Ask Vivo, with the query attached
Continuous monitoring keeps watch between committee cycles
What is the rate of cardiac events in my study?
Are any adverse events clustered by site, cohort, or dose?
Give me a detailed medical history for this set of participants.
What changed in the safety picture since the last review?
The DSMB story — a week of collation down to under an hour — lives on the Trial Oversight page.
Every use case runs on the same platform.
Trial oversight, monitoring, and portfolio views aren’t separate tools — they’re capabilities of one governed platform that spans plan, run, and prove — on one governed foundation.
