VERA FOR PHARMA
Vera’s AI agents run review workflows across medical, regulatory and safety teams. Every approval stays with a qualified person, and Ledger256 proves who signed off, on what, and when.
TWO DECADES IN PHARMA
300+
regulated pharma websites run by ICON under SLA, with 24/7 support, a 12-hour response time in every contract and in-house forensics. Vera brings that discipline to AI.
THE RULES YOU ALREADY LIVE BY
Secure, computer-generated, time-stamped audit trails for electronic records and signatures.
Audit trails for GMP-relevant changes in computerised systems, reviewed regularly.
Human oversight and automatic logging for high-risk AI systems.
Ledger256 extends the audit trail you already validate to cover what the AI suggested, not only what people did.
WHERE VERA HELPS
WORKFLOW
VERA DOES
A QUALIFIED PERSON DECIDES
ON RECORD IN LEDGER256
Promotional review
Checks every claim in materials and web content against the label and approved references, and flags what doesn’t match
Medical, legal and regulatory reviewers approve
Claims checked, references used, each sign-off
Safety intake
Screens inbound reports and enquiries for potential adverse events and drafts the initial case summary
The safety team confirms or closes
Report, assessment, who confirmed
Content change control
Monitors approved digital content and flags any change that hasn’t gone through review
The content owner approves or reverts
Change found, decision, time
Every flag points to the label section or reference it came from. Vera prepares the review; nothing is approved until a qualified person signs, and Ledger256 records who signed and what they saw.
THE PILOT
At week 8 you decide, based on your own numbers. The fixed validation fee is fully credited toward deployment.
BEFORE WEEK 1
Supplier qualification, IT security and data-protection review, pilot agreement.
WEEKS 1–2
Choose one workflow, agree success criteria with Quality, load the approved references.
WEEKS 3–8
Vera works alongside your reviewers on past or synthetic material.
WEEK 8
Go or no-go, measured against your criteria. Stop at any point.
YOUR COMPANY PROVIDES
ICON PROVIDES