Bionabu® · Vera Simulate™
Clinical Trial Risk Assessment Tool
Rehearse the protocol. Find where endpoints break. Fix it before first patient in.
Feasibility asks whether your study will fill. Vera Simulate™ asks whether it will capture its endpoints, and answers before first patient in, while change is still free.
A risk predicted before first patient in is the same event a monitor later sees as a deviation.
One readout before first patient in
See where your study is fragile, visit by visit
Readiness scores, a protocol stress map and the three risks that matter most, on one page for senior teams. The full assessment sits behind it.
Executive summary · sample
Endpoint capture risk
Protocol rehearsal of NCT07530835, a published paediatric study with five intraoral-scan timepoints
The primary risk is endpoint capture, not recruitment.
Protocol stress map · capture-risk index by visit
Level and human driver per visit
What a recruitment-focused review would miss. Every endpoint in this study comes from one repeated scan. A single distressed moment at baseline or straight after treatment can void the primary and secondary endpoints for that child at once. The highest-value protection is upstream: making two specific scans capturable.
Complementary, not competing
A different question from feasibility, asked earlier
Traditional feasibility
Can we recruit?
- Sites
- Patients
- Enrolment
- Answers
- Will the study fill?
- Owner
- Feasibility
- Timing
- At or after site activation
- Unit
- Sites and patient counts
Vera Simulate™ rehearsal
Can we capture the endpoint?
- Protocol
- Participant journey
- Capture vulnerability
- Endpoint readiness
- Answers
- Will it collect usable data?
- Owner
- Clinical Operations and RBQM
- Timing
- Before first patient in
- Unit
- Each endpoint and capture event
Feasibility fills the study; rehearsal protects its data. A study can pass feasibility and still lose its endpoints.
Know where it breaks
A protocol risk register, ranked by endpoint impact
Each endpoint is mapped to the capture events it depends on. Every predicted failure point is scored on likelihood and severity, where severity means what the failure does to the data, not how it feels in the room.
- R1T0 · Baseline scan qualityA poor baseline contaminates every later comparison.Critical
- R2T4 · Final-visit attritionLoss before the last visit; the endpoint is unrecoverable.Critical
- R3T1 · Post-treatment distressMovement or refusal voids the most fragile scan.High
- R4T3 · Out-of-window visitsFading compliance puts the 1-month point at risk.High
- R5T2 · Missed or partial visitScheduling friction removes the 2-week point.Medium
Know why it breaks
The human driver behind each risk, with its evidence
Each risk is traced to the behaviour that causes it and to a specific readiness lever. Every prediction carries a confidence level: structural, when the protocol makes it certain, or evidence-based, to calibrate once the trial runs.
Targeted preparation tools go only where the risk is: a short storyboard, a visual visit schedule or a checklist. The rest of the consent material stays as it is.
- T0 · UncertaintyFamiliarisation before the visit; calm exercise at the chair.High
- T1 · Fatigue and distressRehearsed behaviours, faster workflow, in-visit quality flag.High
- T3 · Reduced motivationMilestone framing, reminder cadence, window management.Mod–High
- T4 · Perceived low valueFrame the final visit early as the one that completes the study.Mod–High
- Baseline anchors every comparisonEntailed by the protocol: every endpoint is a change from T0.Structural
Know what to watch
A deviation forecast, handed to Vera Deviate™
Each predicted risk becomes the deviation it would generate, the monitoring signal that would catch it first and the trigger to act. Signals are written to be configured in Vera Deviate™ at study start, so the trial confirms or revises the forecast instead of rediscovering it from lost data.
- R1Forecast deviationUnevaluable baselineLeading signalFirst-pass baseline acceptanceAct if an unusable baseline isn't caught in-visit
- R2Forecast deviationLoss to follow-upLeading signalAttrition curve vs projectionAct if T3 → T4 drop-off exceeds plan
- R3Forecast deviationMissed or unevaluable scanLeading signalRe-scan and distress events at T1Act if events run above expected for T1
Know whether to test it live
A clear decision on physical simulation
Vera Simulate™ is an analytical rehearsal. It tells you whether mock visits, family testing or PPI walkthroughs would add value, and exactly where to focus them. Most protocols don't need a physical rehearsal, and none need one end to end.
- Primary endpoint at riskYes
- Human behaviour dependencyYes
- Multi-step operational procedureNo
- Optimal mitigation unclearNo
- Protocol refinement likely requiredNo
- Major unresolved uncertaintyNo
How it works
The protocol changes. The process doesn't.
An expert-led rehearsal run on our proprietary simulation model. The same seven steps apply to any protocol and therapeutic area.
Inputs · from the protocol
- Endpoints and how they depend on each other
- Visit schedule and visit complexity
- Population and cohort risk factors
- Capture procedures
- Participant burden and retention exposure
- Mitigations already available
Process · seven steps
- Map each endpoint to its capture events
- Walk the participant journey, visit by visit
- Identify capture vulnerabilities and human drivers
- Score likelihood × endpoint impact into a risk register
- Compute readiness scores from the register
- Forecast deviations and assign the signal that detects each
- Deliver the readout and hand off to Vera Deviate™
Outputs · your report
- Readiness scorecard
- Protocol stress map
- Risk register with evidence and confidence
- Mitigation plan with a named owner per risk
- Deviation forecast with monitoring handoff
- Physical simulation decision
No patient-level data required
Run before protocol lock or first patient in
Who uses it
One report, because each team owns a different link
Clinical Operations
What to change before the study opens, with a named owner for every risk.
RBQM
The deviation forecast, signals and triggers, defined before the trial begins.
Patient Engagement
Why each risk emerges, and where preparation reduces it.
Feasibility and start-up
An endpoint view alongside recruitment, and the failure modes to brief sites on.
Trial Innovation and Portfolio
A repeatable readiness gate to compare studies and govern launch decisions.
Data management
A first-pass quality standard and point-of-capture flags, set before enrolment.
The Vera Platform™
One continuous view of trial integrity, before and after first patient in
Vera Simulate™ forecasts where the study will break. Vera Deviate™ governs whether it does. The risks, deviations and signals carry across, so nothing is rediscovered.
Clinical trial risk assessment: rehearse the protocol, score readiness, forecast deviations.
You are hereProtocol deviation management software: capture, review and close every deviation in one inspection-ready record.
Explore Vera Deviate™Questions teams ask
Clinical trial risk assessment: common questions
What is a clinical trial risk assessment tool?
It identifies what could stop a study from producing usable, reliable data, and ranks those risks so the team can act before they occur. Vera Simulate™ focuses on endpoint capture: it rehearses the protocol visit by visit and shows where endpoints are likely to be lost, why, and what to change before first patient in.
How is Vera Simulate™ different from a feasibility assessment?
Feasibility asks whether the study will recruit. Vera Simulate™ asks whether it will capture its endpoints once participants are enrolled. The two are complementary: a study can pass feasibility and still lose endpoints at baseline, straight after treatment or at the final visit.
What do you need from us, and do you use patient data?
We work from the protocol: endpoints, visit schedule, population and capture procedures. No patient-level data is required. Sponsor parameters such as target enrolment or cost per procedure can be added to size the operational case, but they are optional.
Is Vera Simulate™ software we run ourselves?
No. Each rehearsal is expert-led by the Bionabu team using our proprietary simulation model. You receive a readout for senior teams and a full assessment with the risk register, mitigations, deviation forecast and monitoring handoff.
How does it support ICH E6(R3) and risk-based quality management?
ICH E6(R3) asks sponsors to identify factors critical to quality and manage risks to them in proportion to their importance. Vera Simulate™ produces that analysis for endpoint capture before the trial starts, with named owners, and pre-specifies the signals your RBQM team monitors once it is live.
Does it replace mock visits, PPI or patient engagement?
No. It decides whether a physical simulation is worth running and where to focus it, so you test the few high-risk moments rather than the whole protocol. Patient engagement and PPI stay in place; the rehearsal tells them where to aim.
What happens after first patient in?
The forecast deviations and monitoring signals are configured in Vera Deviate™, our protocol deviation management software. Observed deviations are then compared against the forecast, which confirms or revises the rehearsal.
Evidence base
An established method, applied where it has the most leverage
Vera Simulate™ applies clinical simulation and human-factors analysis at the moment before first patient in, when the protocol and operational plan can still absorb change.
Published precedent · Paediatric Drugs, 2025High-fidelity simulation of a paediatric trial's key visits identified risks and needs before protocol finalisation, and framed the value as return on investment and return on engagement.
Read the studyScope, stated plainly
- Simulation-based and predictive; scores are directional and calibrated against your own data during the trial.
- Does not assess clinical efficacy or safety.
- Not a regulatory submission, and not a substitute for feasibility, statistical or quality review.
- Preparation tools supplement the ICF and the consent conversation; they go through ethics committee review.
Bring one protocol. We'll show you where it breaks.
See a sample readout, or walk through your own protocol with our team in 30 minutes.