From protocol intent to protocol execution.
Bionabu connects what happens before the visit and during the study — turning protocol intent into execution.
One system. One continuous view of risk.
Protocol deviations don’t start in the system — they start in confusion.
Less manual work. Fewer deviations. Better retention.
We didn't start with Vera.
We started with patients.
The first work was in pediatrics — helping families understand the trial before the visit, before the consent, before participation. Visual preparation, age-calibrated, in the patient's language. The kind of preparation that turns confused parents into informed ones, and nervous children into engaged participants.
But very quickly, the same problem appeared in every study we touched: even when patients arrived prepared, the teams running the trial were still managing protocol deviations across spreadsheets, email threads, and EDC exports nobody designed for human reading. Hours of reconciliation every week. No unified picture of where the real risks were. The chaos that better patient preparation alone could never fix.
So Vera wasn't a second product. It was the necessary downstream completion of the same problem. If we wanted to genuinely improve trial outcomes, we needed to prepare patients before the visit AND support teams during the study.
One closed loop. Built in the order the work demanded.
Patients arrive prepared.
PrepStoriesAI® and Visit Before the Visit® work before patients reach the clinic. They explain what the protocol asks for, in age-appropriate language. They reduce the misunderstandings that become deviations.
Deviations captured early.
Vera Deviate™ runs during the study. It consolidates protocol deviations from any EDC, any site log, any biosample log into one workflow. Role-based review, audit trail, AI-surfaced trends. Caught before they accumulate.
Less manual work for the team. Fewer deviations. More stable protocol execution. Better retention.
We don't sell a concept. We build the working tools — before and during the trial — that turn protocol intent into protocol execution.
Others focus on patient experience. We focus on keeping the trial on track.
There are platforms that improve how patients feel about a study. Bionabu is not one of them. We are clinical operations infrastructure that prevents deviations upstream and governs them downstream.
Prep tools improve behaviour. Vera ensures the study stays on track.
A signed ICF doesn't mean the patient understood it.
A signed informed consent form without genuine comprehension produces deviations downstream — incorrect procedures, missed visit windows, withdrawal before the protocol completes. The signature is a moment. Understanding is a sequence.
Visit Before The Visit™ guides patients through five stages of understanding — from first hearing about the trial to staying engaged through to the end:
Each phase of the trial — invitation, understanding, assent, participation — uses age-appropriate visual content that helps the patient move from one stage to the next. We don't use animation because patients prefer it. We use it because patients actually understand more when information arrives in multiple modes — text alone produces compliance, not comprehension.
The result: understanding that holds across the trial arc, not just at the moment of signature. Fewer ICF-related deviations. Better retention. Stronger audit trail.
How the closed loop works in practice.
Industry data: ICF-related deviations average ~14% of all protocol deviations, and have been reduced by ~57% with improved consent processes (IQVIA analysis of approximately 12,000 consent-related deviations).
Patients sign consent forms they don't fully understand, then make mistakes during the study — incorrect sample handling, missed visit windows, withdrawal before the protocol completes. ICF-related deviations are not the most numerous category, but they are among the most expensive — high-impact, often classified critical or major, and concentrated in trials with vulnerable populations.
PrepStoriesAI improves ICF understanding upfront. Visual assent storytelling explains placebo, randomization, and procedures in age-appropriate language before consent is signed. Patients arrive with informed understanding, not confusion.
Vera Deviate™ governs any ICF-related deviations downstream. Captured early, reviewed under role-based workflow, traceable in the audit trail. CAPA-ready evidence for inspection.
One problem. Two ends. Same team.
Protocol deviations live in five places. None of them talk to each other.
What every senior CPM running a multi-country trial currently spends Sunday evenings reconciling.
Audit trail exports nobody designed for human reading.
Per-site Excel. Eleven sites means eleven formats.
Separate vendor system entirely.
Some sites still log deviations on paper at intake.
Deviations the CRA caught during monitoring, lost in threads.
Reconciliation happens at midnight on Sundays. Inspection prep starts with a panic.
One system. Five sources. Zero reconciliation.
Vera works with any EDC, any study, any SOP. Not just one vendor's stack.
- Role-based review
- Staged PD governance
- AI trend surfacing
- 21 CFR Part 11 audit trail
- Configurable to any EDC, any protocol, any SOP — not locked to one vendor
- Patient-level, site-level, and biosample deviations in one workflow
- Role-based access for CRA, Lead CRA, CPM, Medical Monitor, BOM, QA, Sponsor
- 21 CFR Part 11-aligned audit trail, electronic signatures with re-authentication on close-out
- Ask Vera — natural language query over your own data, scope-respecting and cited
- AI-surfaced trends across sites and categories for CAPA conversations and vendor management
Cutting PD admin time from hours of manual uploads to a single import per cycle.
Where Vera fits.
Production deployment
Tier-1 CROs and sponsors running multi-country observational and interventional studies. Vera replaces fragmented per-site Excel logs, weekly reconciliation, and email-thread audit trails. Configured to your study in roughly 48 hours. No IT integration required.
Mid-size CROs and biotech sponsors
Teams running their first observational study or a vendor-managed study where the CTMS doesn't cover PD tracking properly. Vera deploys faster than enterprise tools and at a fraction of the cost.
Clinical operations training
Vera is also deployed as a training tool for clinical operations students and micro-internship cohorts. Trainees practice PD logging, role-based review, audit trail navigation, and CAPA workflow on production-grade software. Builds the next generation of CRA Ops talent on the same tool the industry uses.
Why a tier-1 CRO chose Vera over Excel.
How a multi-country observational cardiology study replaced fragmented PD tracking with one source of truth.
Like most CROs, this team was managing protocol deviations across EDC exports, per-site Excel logs, and email attachments. Weekly PD review meant hours of manual copy-paste, unclear ownership, and limited audit trail when a sponsor or inspector asked: "Show me your deviations and how you reviewed them."
They deployed Vera to consolidate all PDs into a single workflow, cut manual admin, and put visible governance around a process that previously lived in spreadsheets.
A multi-country observational cardiology study run by a tier-1 global CRO for a European pharma sponsor. Vera consolidates protocol deviations across sites in Germany, the Czech Republic, and Argentina. Replaces per-site Excel logs and weekly manual reconciliation. The reference deployment for Vera's 21 CFR Part 11-aligned audit trail and role-based 4-stage review workflow.
CRO and sponsor under standard vendor non-disclosure. Reference call available on request, subject to mutual NDA.
Pilot pricing. For our first three studies.
No hidden implementation fees. Cancel anytime with 14 days notice.
- One study, unlimited users
- Full PD workflow with 4-stage review and audit trail
- User management, exports, logic and bug fixes, system updates, support
- Dashboard available as add-on
- Everything in Base
- Vera Dashboard included — real-time PD trends, CAPA status, inspection-readiness view
- Priority support
- First three pilot clients only
- Multi-study volume pricing
- White label option
- Custom SLA + DPA
- Dedicated account management
Pilot pricing reserved for our first three pilot studies. Standard pricing increases for subsequent studies once the reference base is established.
Three products that prepare patients before the visit.
Active deployments in Colombia, India, Switzerland, and a leading European pediatric academic hospital.
Pediatric pre-visit preparation, clinician-reported outcomes.
Visual pre-visit pathways delivered to families before pediatric dental and tongue-tie consultations. Active deployments at JC Odontopediatra (Colombia), Toothtales Clinic (India), and Erdodent (Switzerland). Outcomes captured at point-of-care via clinician and patient feedback.
Early pilot data from JC Odontopediatra. Full case study Q3 2026.
AI-assisted clinical trial assent for ages 12 to 15.
Visual assent storytelling for pediatric clinical trials — explaining placebo, randomization, and double-blind protocols to adolescents in age-appropriate language. Currently deployed at a leading European pediatric academic hospital under non-disclosure (108K+ followers, 900+ educational videos).
Reference call available on request, subject to mutual NDA.
Measuring engagement, comprehension, and adherence.
The behavioural research arm of Bionabu. Captures engagement, comprehension, and adherence data across all pediatric deployments. Feeds evidence back into Vera's quality intelligence layer and into product design across the ecosystem.
Outcome data informs both pediatric content design and clinical trial PD prevention strategies.
Built by a CPM who lived this work for fifteen years.
Bionabu's founder ran clinical operations across pharma, CROs, and pediatric care:
- Clinical Trial Manager at PPD
- Seven years at Medpace across CRA III, Lead CRA, and Clinical Trial Manager roles in the UK and Germany
- Multi-country observational and interventional study delivery
- Pediatric trial design experience across European academic hospitals
Vera Deviate™ is the tool she wishes she had on every multi-country study she rescued. PrepStoriesAI and Visit Before the Visit® address the upstream problem she watched cause deviation after deviation in pediatric trials.
Same standards. Same measurement rigor. Same founder.
Reimagining Informed Consent: AI Avatars in the Era of Complex Clinical Trials
Lead author: Ina Burgstaller (Bionabu founder). Co-authors: Martin Heitmann (ISPE GAMP Steering Committee), LaToya Hinton (CEO, Next Innovative Clinical Research; experience across Northwestern University, Rush University, University of Chicago), Brandi Stockton (Co-Lead, GAMP Global Software Automation and Artificial Intelligence Special Interest Group).
Peer-reviewed analysis published in Pharmaceutical Engineering, the official journal of the International Society for Pharmaceutical Engineering (ISPE), examining how AI-supported consent processes improve participant comprehension, reduce ICF-related deviations, and align with GAMP 5 and ICH GCP guidelines.
The thinking behind PrepStoriesAI — applied operationally inside Vera Deviate™.
Read the paper →Based in the UK · serving teams across Europe, Latin America, and South Asia.
Three steps from Excel to Vera Deviate™.
Book a 15-minute overview
We show you a live demo configured for a real multi-country observational study, not a generic sandbox.
Share your study documents
Monitoring plan, site list, PD categories, EDC system. We configure Vera to your actual study in 48 hours.
Your team starts logging
CRAs, Medical Monitor, BOM — all with role-appropriate access from day one. Full audit trail from the first deviation.
Or email info@bionabu.com — we respond within one working day.