About Vera Platform by Bionabu
Built by someone who has done your job.
Vera was designed by a former CRA, lead CRA, clinical project manager and vendor manager, for sponsors and CROs who keep oversight of protocol deviations every day.
Live and deployed: one observational study, 106 sites, 8 countries
Where Vera comes from
Every operational role in the deviation chain. Then I built the tool.
I’m Ina Burgstaller, founder of Vera Platform. For more than 20 years I worked on the inside of clinical trials, in the operational roles that touch every protocol deviation.
The problem was never a lack of data. Deviations sat in the EDC, in trackers, in emails and in people’s heads, and oversight depended on someone holding it all together by hand.
I didn’t start from an idea. I started from demand.
My clients kept asking for a tool that didn’t exist, so I became the vendor and built it for them. Not an IT dashboard, but a process built from experience, mirroring how studies really run.
Vera takes the reconciling and chasing off the people who hold the study. CROs hand over finished cases. Sponsors decide on a complete record, and can defend every decision.
- CRAReconciled deviation logs line by line, site by site.
- Lead CRAManaged CAPAs and trained other CRAs to enter and classify deviations the same way.
- Clinical project managerHeld the review meetings with sponsors, working from spreadsheets and disconnected teams, and kept it defensible at audit.
- Vendor managerManaged vendors, deviation work included. Sponsors wanted tools that didn’t exist, and the parts that did weren’t built to work together.
- Founder, Vera PlatformClients asked me to build it. So I did: Vera.
The team
Who you’ll work with
Ina Burgstaller
Founder, Vera Platform
Designs Vera’s workflows and leads each study’s process design, from SOP mapping to go-live.
Sabrina Abdula
UAT Lead and Configuration Coordinator
Configures each study’s roles, sites and access, and leads user acceptance testing before go-live.
What we believe
Four principles behind every screen
Your source stays your source
Vera is a governance layer, not another database to keep in sync. Your EDC and logs remain the source. Vera is where deviations get reviewed, decided and documented. No migration, no new system for your sites.
Smart engineering, not AI hype
No AI makes judgements. Vera flags possible duplicates and missing fields, and your team stays in control: a CRA can override a flag, a reviewer can request changes, and the sponsor, who enters nothing, makes the final decision. Every decision is recorded with a name, role and timestamp.
Four eyes. By design.
The person who creates a case doesn’t review it. It’s the four-eyes principle, the same logic you already apply to drug accountability.
Fit the study, not the other way round
If your process calls it a data review meeting, so does Vera. We adapt roles, review steps and terminology to your SOP.
How we work with you
Your workflow first, not a sales script
We show Vera on your study
Not a generic demo. We configure Vera to your PD specification and SOP, then walk you through your own review chain.
We tell you what’s there
What Vera does today, what is configurable and what isn’t there yet. If another tool is a better fit for you, we’ll say so.
Every role gets trained
Vera Academy gives CRAs, CPMs and sponsor reviewers short, role-based modules, so the process holds up after go-live, not just in the demo.
What’s behind Vera
One platform, built around deviations
Protocol deviation management from entry to final decision, with a full audit trail ready to file in your eTMF.
→ Vera Simulate™Finds the gaps before first patient in, so Vera Deviate goes live configured. Built on our experience in pediatric trials, where visit burden and consent are hardest to get right.
→Role-based training for every team that touches deviations.
Tell us how your deviations are handled today.
30 minutes on your workflow, and whether Vera fits.
Book a walkthrough →We sign your NDA before you share anything.