Protocol Deviation Management

Know where your protocol will break before first patient in, and govern every deviation after.

Before first patient inStress-test your study During the trialGet your study configured

We sign your NDA before you share anything.

What sponsors and CROs get from Vera

Keep oversight of every deviation

You can delegate the work. You can't delegate the oversight.

  • Notified as soon as a deviation you care about is entered
  • Reviewed before the meeting, not in it
  • Every site and CRO in one deviation log
  • Sign-off under 21 CFR Part 11, with a full audit trail
Deviation LogAudit Trail
Total23
Open5
Major3
Locked12
Deviation IDCurrent stepCycle
ABC-301-PD-046Site 10001 Informed consent · outdated versionMajorSponsor review New
ABC-301-PD-027Site 10004 Excluded concomitant medicationMinorScientific Review 83d
ABC-301-PD-041Site 10001 Procedure deviationMinorLock Decision 79d
Next actionSponsor: review and sign offSign off

For illustration only, with fictional data. Vera is configured to your study's protocol and PD categories.

Why Vera?

Built for messy reality

Deviations live in manually written logs, EDC exports, email and people's heads. Vera brings them into one governed record.

Earlier

Stress-test your study before first patient in, and settle protocol ambiguity before it becomes an amendment or a deviation.

Precise

Vera recommends the minimum sufficient intervention, not the maximum amount of content. Your team decides.

Bring us one protocol

Before first patient inStress-test your study During the trialGet your study configured

We sign your NDA before you share anything.

Book a free study check

Tell us where your study is. We'll look at one part of it with you and show where deviations are likely to start, or where they're getting lost.

What you get

  • A 30-minute call with a clinical operations specialist
  • A one-page summary of what we found
  • No documents needed to book. We sign your NDA before you share anything.