Bionabu® · The Vera Platform™
Clinical Trial Risk Management Platform
Active simulation. Controlled deviations. One platform.
Where trials lose control
Two moments decide trial integrity
Vera Simulate™
Test reality before reality tests you.
Study risk is cheapest to fix before the first patient. See where the protocol will break, and prepare patients before it does.
Vera Deviate™
Control deviations as they happen.
The EDC is too basic for deviation oversight. Bring site logs, biosample logs and EDC exports into one clean digital record.
Before first patient in · Protocol simulation software
Vera Simulate™
Test reality before reality tests you.
Vera Simulate™ validates your study design using a simulation database of protocol deviations, shifting risk management to proactive mitigation before start-up.
Request a sample reportThe Vera Simulate™ system · Clinical trial risk mitigation
Predict the risk. Prepare the patient. Govern the evidence.
CRAs flag risks. Sites lack time to fix them. Deviations repeat. This system breaks the loop.
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Step 1
Predict
Find where the study design will generate deviations, before start-up.
40% of deviation risks predicted before study start-up Structural analysis · Vera Simulate™ -
Step 2
Prepare
Targeted patient tools only where the risk is: storyboards, visit schedules, checklists.
Participants who felt very confident deciding whether to take partAI avatar video100% Paper ICF60%Field study · Pharmaceutical Engineering, 2025 -
Step 3
Govern
Lock versions and review chains, so sites re-consent with current approved material.
<1% of consent and re-consent events on an outdated version Compliance standard · version lock
Free study risk self-assessment · 3 minutes
Is your study at risk of deviation loops and inspection gaps?
Get an instant, itemised score showing where deviations are likely to slip through, and what to fix first.
For clinical operations, quality and study teams on pharmaceutical, medical-device and combination-product studies.
Your result
Questions 1–6. Lower is better.
Questions 7–10. Higher means oversight is likely to be harder.
Where to look first
Medical-device investigations: also consider device deficiencies, malfunctions, use errors, software or configuration changes and operator training, both as causes and as corrective actions, and device-related safety or performance data.
This score indicates the likely value of more structured deviation oversight. Confirm the result against your study risk assessment, applicable regulations, SOPs and inspection-readiness requirements.
After first patient in · Protocol deviation management
Vera Deviate™
Control deviations as they happen.
Every source in one controlled record. Role-based review, 21 CFR Part 11 sign-off.
Vera Academy · Micro-lesson 1
Role-based micro-learning, built into deployment
Each role completes only the micro-lessons for its own steps.
Who we serve
Built for the people accountable for trial integrity
Sponsors & CROs
Running studies that must stand up to inspection, from protocol design to closure.
Clinical ops, data & QA
Owning deviations, CAPA and inspection readiness beyond what the EDC tracks.
Labs & biosamples
Logging processing and storage deviations in the same controlled record as the rest.
Pediatric centres
Preparing children and families with age-appropriate, EC-reviewed materials.
Questions teams ask
Common questions
Vera Simulate™ · before first patient in
What does a protocol risk simulation show before study start-up?
Where your study design is likely to generate deviations: eligibility criteria, visit windows and schedules that put endpoints at risk. The readiness report names the primary risk, so you can redesign or mitigate before an amendment forces it.
Do we need to turn our whole ICF into video?
No. That is rarely economical. The simulation, or your live deviation data, identifies the few procedures and visits most likely to cause deviations. Targeted tools go only there: a short storyboard, a visual visit schedule or a checklist. The rest of the ICF stays as it is.
Does it replace the ICF or the consent conversation?
No. Each tool is scripted from the approved ICF wording and goes through ethics committee review. It prepares the patient for the consent conversation with the study team.
Vera Deviate™ · after first patient in
Can we keep our EDC?
Yes. Sites keep entering clinical data in the EDC. Vera Deviate™ imports EDC exports alongside site deviation logs and biosample logs into one reviewed record.
Our CRO manages deviations. Why does the sponsor need its own view?
Under ICH E6(R3), tasks can be delegated but the sponsor stays responsible for oversight. A live, role-based register shows classification, trends and closure between CRO reports.
How are biosample and lab deviations handled?
Biosample logs import at their own level, escalated by default, in the same controlled record as patient and site deviations.
Peer-reviewed
We didn't invent it. We standardised it.
Published in Pharmaceutical Engineering (ISPE GAMP, 2025) and applied in clinical studies and ethics-reviewed patient communication projects.
Read the article in Pharmaceutical EngineeringSchedule a Platform Walkthrough
Speak with a clinical operations specialist to see how Vera Deviate™ can automate your deviation governance and secure an inspection-ready trial record.