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.

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ABC-301-PD-046Site 10001 Informed consent · outdated versionMajorSponsor review New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