Vera Deviate™ · Vera Platform by Bionabu
Protocol Deviation Management Software
We are your filter.
For academic and commercial studies. Find each deviation in the first place, then control every decision until it is closed.
We sign your NDA before you share anything.
A deviation log
- Record
- Review
- Close
Controls the entry.
Vera Deviate™
- Detect
- Challenge
- Resolve
- Correct
- Close
Controls whether the decision was right.
1
Deviation log for all your sources
4 eyes
On every case: one person creates it, a separate lead reviews it
0
Changes to your source data: no migration, no integration project
Name · role · time
On every decision
How Vera Deviate™ works on every study, by design.
Academic and commercial
University hospitals run both. So does Vera.
A perfect audit trail of the wrong decision is still the wrong decision.
A log proves what happened. Vera checks that it was right.
Part 1 · Identify
Not every deviation carries the same risk
The FDA’s draft guidance on protocol deviations (December 2024) asks sponsors to focus on the important ones: deviations that could affect participants’ rights, safety or well-being, or the reliability of key study data.
That starts before any review. If a CRA isn’t sure something is a deviation, or which log it belongs in, it never reaches oversight at all.
- 1What countsYour protocol’s own deviation definitions, so every site applies the same rule.
- 2Where it is loggedOne source log for each deviation, not an inbox or a note-to-file.
- 3Which ones matterEach case classified as important or not; critical ones go straight to a named decision-maker.
What to report, and what not
Example data · your protocol decides the final rule
Important deviation
Log it, and a named decision-maker sees it straight away.
- Sample taken for optional testing without that consent
- Participant dosed outside eligibility criteria
- Safety assessment missed at a key visit
Deviation, not important
Log it once, in one source log, for the regular review.
- Visit outside the protocol window
- Questionnaire completed on the wrong day
- Lab sample processed later than specified, result still usable
Not a deviation
Handle it where it belongs, not in the deviation log.
- Visit rescheduled within the allowed window
- Data-entry typo corrected through a query
- Site staff change or administrative update
Over-reporting buries the deviations that matter in noise. Under-reporting hides them, including the ones inside closed queries. Vera Deviate uses your protocol's definitions so every site applies the same rule.
Who enters what
Your source stays your source
Built for studies that run on an EDC, spreadsheets and paper logs. Sites keep entering deviations where they do today. Your CRO brings them into Vera for review. Vera reads your exports and never writes back.
No migration, no integration project, no new system for your sites.
Capture deviations from every source
Your sources record the deviation. Vera adds what your SOP needs.
EDC and site logs weren’t built for deviation oversight, so fields your SOP requires are often missing. Vera brings each deviation in from its source and flags what’s missing, and your CRA completes it before review starts.
- Missing SOP fields flagged on import, ready for your CRA to complete.
- Repeats flagged within each source. No AI: your CRA confirms or overrides, so updates are never hidden.
- Linked back to its source. Vera adds the review, not a second copy.
Part 2 · Control
Closed loop, not just a closed log
- DetectIs it a deviation? Which log?
- ChallengeA second reviewer can disagree
- ResolveThe right role settles it
- CorrectReclassify, with a reason
- CloseName, role, time. Locked.
A classification that differs from your protocol guidance stays flagged until it is resolved. Not a warning that disappears on save.
“Do not concur” sends the case back. It can’t reach sponsor sign-off until review is complete.
Work carries on, but a material conflict can’t be closed without a documented decision.
Where you come in
Review by role, with a clear owner
Who does what, from entry to final decision. Pick your side and watch one deviation move through the review chain, including the moment it comes back.
Four-eyes review: the person who creates a case can’t operationally review it.
You don’t enter deviations. You decide.
- CRAEnters and classifies
- Clinical PMOperational review
- Medical MonitorMedical review
- SponsorDecides
- RecordLocked
The CRA enters the deviation and classifies it against your categories.
Example case, real workflow. Vera is configured to your roles, protocol and PD categories.
Time-critical
Critical deviations don’t wait for the meeting
Routine deviations go to your data review meeting. Critical categories, such as consent or sample issues, go straight to a named decision-maker.
- You choose what’s critical. The categories, and the decision-maker for each, are configured to your protocol during study setup.
- Straight to a named decision-maker, without waiting for the meeting. Your CRA sends the case as soon as the deviation is entered.
- Nothing stalls unseen. Every case shows its current step and age, so late entries are visible.
- Timely entry is trained. Vera Academy trains CRAs and sites to report time-critical deviations immediately.
Notifications for your critical categories can be configured during study setup.
Illustration only. Your critical categories and decision-makers are configured to your study.
The record
Every deviation, every site, in one place
One auditable log with status, owner, current step and age, instead of a dozen spreadsheets. Open a case to see its file and every back and forth in its audit trail.
- Classification
- Category
- Site · subject
- Date of deviation
- Source
- Current step
- Root cause · CAPA
- Four-eyes review
Click a deviation to open its case file. PD-0041 shows the back and forth.
Example case, real workflow. Vera is configured to your roles, protocol and PD categories.
Traceable to closure, audit-ready
- CAPA on the case: root cause, correction and prevention, recorded with the deviation.
- Every change is kept with the name, role and UTC time of whoever made it.
- Decided and locked: once the final decision is recorded, the record can’t be changed.
Coming soonNeed CAPAs beyond deviations? The Vera CAPA module will track protocol and non-protocol CAPAs in the same audit trail.
From signed to live
Live on your study in 3–6 weeks
- Specifications
- Configuration call
- UAT sign-off
- Go-live
- Onboarding
Configuration, testing and role-based onboarding in Vera Academy are included. Study-specific training can be added.
Questions
Questions sponsors and CROs ask about protocol deviation management software
Does it work for academic, investigator-initiated studies?
Yes. Vera is configured per study, so a university hospital can run its own academic studies and commercial studies for industry sponsors, each with its own deviation definitions, review roles and escalation rules.
What does protocol deviation management software do?
It gives sponsors and CROs one controlled record of every protocol deviation: captured from every source, reviewed by role, decided and closed, with name, role and time on each step. Vera Deviate does this from your exports and logs, without changing your source data.
Can it link to our EDC or CTMS?
It works from exports, with no live sync, so your source data stays untouched. An API integration with your EDC or CTMS can be scoped if you need one.
Can we export the record?
Yes. The deviation listing and audit trail can be exported, including for your eTMF.
Who can access the system?
Only the people on your study’s user list, each with role-based access: they see and do what their role allows. Vera is hosted in the EU.
How is it priced?
Per study, scoped to your sites and roles. Configuration and Vera Academy onboarding are included.
- Vera hosted in the EU
- GDPR
- DPA on request
- Role-based access
- Append-only audit trail
Bring one study’s deviations. We’ll show you the record.
See your own deviation log consolidated into one auditable view in a 30-minute walkthrough.
Book a walkthrough →We sign your NDA before you share anything.