Vera Deviate™ · Vera Platform by Bionabu
Protocol Deviation Management Software
A deviation log that controls the decision. Not just records it.
Vera Deviate™ is protocol deviation management software that gives sponsors an independent, auditable view of the deviations that matter most, configured to your protocol and read-only next to your EDC.
Live across 100+ sites in 8 countries
Deviations live in many places. The decision is often nobody’s.
EDC queries, spreadsheets in v3 and v4 FINAL, paper site logs and email threads. A case is downgraded and nobody is told. Months later, an inspector asks who decided.
Who it’s for
Built for the deviations that matter most
Smaller biotech sponsors
Fewer in-house resources and outsourced CRAs. A clear review path, with guidance and review support if you need it.
Time-critical deviations
Early-phase eligibility, consent, IMP, or cell and gene therapy manufacturing windows. The right person is told while there is still time to act.
Mature sponsors with a gap
Keep your CTMS and EDC. Use Vera for a defined, high-priority subset of deviations.
Proportionate by design: live escalation where timing matters, periodic review where it doesn’t.
Capture every deviation, from every source
EDC exports, Excel trackers and paper site logs. Read-only.
Import EDC exports and site logs in controlled batches. Each batch shows what was imported and which rows need attention before review starts. Nothing is written back to your sources.
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Your categories, built in
Your PD assessment spreadsheet, per protocol.
Bring your own spreadsheet. Your categories and examples are loaded at configuration, so CRAs choose the category with your examples in front of them, and every site applies the same rule.
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Review by role, with a clear owner
Review depth set by risk, per study.
The CRA reports. For the deviations that matter most, a separate reviewer decides importance and CAPA, with scientific review where needed, and the sponsor signs off or sends it back. Lower-risk deviations can follow a lighter, periodic review. No one reviews their own case.
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Notifications to the right inbox
Escalation where timing matters.
Time-critical deviations, such as consent, eligibility, IMP or a manufacturing window, are escalated by email to the right person while there is still time to act. Downgrades are always flagged. The rest waits for your periodic review, so no one is flooded. Who is told about what is configured with you at set-up.
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Traceable to closure, audit-ready
Name, role and UTC time on every step.
Every question, answer and decision stays inside the case, in an append-only audit trail. Export the listing and the trail to your eTMF at any time.
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Every deviation, every site, in one place
Every case, its step and its next action.
Filter by site, status or step. See which cases are complete and locked, which are waiting in the review queue, and what happens next. Between data review meetings, not after them.
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Our commitment
Your process, configured. Not replaced.
- 100+Sites live
- 8Countries
- 3–6 weeksTo go live, also mid-study
We configure Vera to your protocol and SOPs, read-only next to your systems. Your sources, your rules, your decisions.
Compliance
Built for the oversight inspectors ask about
- ICH E6(R3)Built around sponsor oversight and risk-proportionate review.
- GDPRHosted in the EU. Participant IDs hidden from the sponsor role.
- Audit trailAppend-only. Name, role and UTC time on every action.
- Role-based accessEach user sees only their sites and their role.
- Four eyesNo one reviews their own case.
- eTMF exportListing and audit trail, filed when you need them.
Pricing
Priced per protocol. Live in 3–6 weeks.
Leave your work email and we’ll send you the pricing.
Questions
Questions about protocol deviation management software
We already have an EDC or deviation system. How is Vera Deviate different?
Vera Deviate complements your EDC or deviation system; it doesn’t replace it. Those systems flag potential deviations. Vera is protocol deviation management software for the confirmed ones: each is reviewed by role, decided and signed off, with the decision history and audit trail that sponsor oversight needs.
Do we need live review for every deviation?
No. Vera is configured per study: live escalation for deviations where timing matters, such as consent, eligibility, IMP or time-critical samples, and periodic review for the rest. You can also use it for a targeted subset only.
Is Vera Deviate suitable for small biotech sponsors?
Yes. Smaller sponsors with outsourced CRAs and fewer in-house resources use Vera for a clear review path, with optional guidance and review support from Bionabu.
Can our protocol deviation categories and examples be built into the system?
Yes. We load your PD assessment spreadsheet at configuration, per protocol. CRAs then choose your categories with your examples in front of them, so every site applies the same rule.
Can it be configured to our protocol, with notifications to our inbox?
Yes. Vera is configured to your study specifications and your escalation pathway, including email notifications to the right people. Studies go live in 3–6 weeks.
How does Vera Deviate work with our EDC?
In two ways: import your EDC export in bulk, or have CRAs enter deviations once they are confirmed. Potential or unconfirmed items stay in your EDC. Vera is read-only and writes nothing back.
Can unblinded deviations be kept from blinded staff?
Yes. Access, roles, categories and notifications are set per study, so each person sees only what their role needs.
Can we record a CAPA in Vera Deviate?
Yes. A CAPA can be recorded with each case. An extended CAPA module, aligned to your SOP, is coming as an add-on.
Who has Vera Deviate been developed with?
With clinical operations teams at sponsors, CROs and university hospitals. It is live across 100+ sites in 8 countries, and feedback from every study shapes the product.
How much does protocol deviation management software cost?
Vera Deviate is priced per protocol: a one-off configuration fee, then a monthly fee that includes support, usability check-ins and Vera Academy. Study-specific training and extra modules are add-ons. Request the pricing on this page.
Can we start using Vera Deviate mid-study?
Yes. Sponsors have adopted it partway through a study. Open deviations are imported in bulk, and new ones are entered as they are confirmed.
Is Vera Deviate AI?
No. It runs on your protocol, your categories and your roles, configured with you.
Bring one study’s deviations. We’ll show you the record.
A 30-minute walkthrough of our protocol deviation management software, built on your own PD spreadsheet.