Find protocol design risks before the first patient is enrolled.
Upload a Phase 3 protocol. AuditRx compares it with the failure modes of terminated, suspended and revised trials in its drug category, then returns a risk report with a corrective action for each finding.
No credit card needed. Reports download as Word or PDF.
5.2 Exclusion criteria
Participants are excluded if they have any prior exposure to a drug in this class, more than two prior lines of therapy, or any of 14 listed comorbidities.
7.1 Schedule of assessments
The primary endpoint visit occurs at Week 12 (window: ±1 day), requiring an in-clinic infusion and imaging on the same day.
One protocol, four expert reviews
Each report looks at your design from the people who will run, join and inspect the trial.
Risk scorecard
Which known failure modes your protocol matches, with severity and a corrective action plan for each.
Site coordinator review
Visit windows, workload and enrollment friction.
Patient advocate review
Participant and caregiver burden, and attrition risk.
FDA auditor review
Ambiguous eligibility rules and GCP compliance exposure.
From upload to action plan
Most audits take a few minutes. You don't need to reformat your document.
Upload your protocol
Drop in a PDF or Word file, up to 50 MB.
Compare against history
AuditRx checks the design against failure modes drawn from Phase 3 trials that were terminated, suspended or revised, matched to your drug category.
Get your report
Download a risk report in Word, PDF or both, and take the corrective actions to your team before enrollment opens.
Your protocol stays yours
Protocols are confidential. Here is how AuditRx treats them.
- Files are visible only to your account.
- Uploaded protocols are not used to train models.
- Data is encrypted in transit and at rest.
- You can delete your uploads and reports at any time.
What AuditRx is, and what it isn't
AuditRx is decision support for protocol design. It flags patterns seen in historical trial failures so your team can review them. It does not replace your regulatory, clinical or statistical review, and it does not predict whether a trial will succeed.
Audit your next protocol before it reaches a site
Run your first audit free, or read a sample report to see what you would get.