For sponsors, CROs and academic research teams
Clinical Trial Oversight
For study protocols where deviations can’t wait.
Tested before.Overseen during.Alongside your EDC.
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- 3–6 wksTo go live, also mid-study
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Without Vera
- ✕Deviations in EDC, Excel and paper
- ✕PD examples v4 FINAL
- ✕A case was downgraded. Nobody told you.
With Vera
- ✓One record
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- ✓You are told, every time
Vera Platform
Clinical trial oversight, before and during your study
Clinical trial oversight for sponsors and CROs, from the first patient to the final decision.
During the trial
Vera Deviate™
An auditable record of the deviations that matter most.
Learn more about our protocol deviation management software →Before first patient in
Vera Simulate™
Pediatric content specifications: assent and patient materials, tested with families.
Explore Vera Simulate →Could you show an inspector who decided?
10 questions. 5 minutes.
How each question is tagged
- FDA regulationBinding law: informed consent and IRB rules (21 CFR 50 and 56)
- ICH E6(R3)Expected under the current GCP standard
- FDA guidanceRecommended in FDA’s draft guidance on protocol deviations
- Good practiceSupports a regulatory goal; how you meet it is up to you
Sources are listed at the end of the self-check.
0 of 10 answered
Your score
/ 10
Your study looks like the ones Vera was built for: deviations from several sources, assessments the EDC can't hold, and critical decisions that can't wait.
Your gaps, most weight first
This self-check is a conversation starter, not an audit or a regulatory assessment. Tags show where each question connects to FDA regulations, ICH E6(R3) or FDA’s December 2024 draft guidance on protocol deviations, which is nonbinding. Bionabu is not affiliated with or endorsed by FDA or ICH.
Sources · Last checked: 1 Oct 2026
ICH E6(R3) Good Clinical Practice: principles and Annex 1 in effect in the EU since 23 July 2025. Annex 2 (decentralised, pragmatic and real-world data trials) was adopted in June 2026 and takes effect on 15 January 2027.
FDA draft guidance Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices (December 2024, docket FDA-2023-D-5016). As of Oct 1, 2026, FDA lists it as current draft guidance, with no newer final or revised version. FDA regulations: 21 CFR 50 and 21 CFR 56.
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