Each service page explains the problem, the standards we work to, how AI is used, the steps we follow, and what you receive. Email hello@clini-gene.com if you are not sure where to start.
GCP audit readiness is not a slide deck. It is whether an auditor can follow a subject, a visit, a deviation, or a consent from the protocol to a filed artifact, and whether your quality system can explain what is missing. CliniGene uses AI to do the first pass of that mapping at scale. A GCP specialist then writes the official findings.
A Vault that is “live” is not finished. Releases arrive, roles drift, tickets pile up, and the SOP no longer matches the screens. CliniGene operates Veeva as a managed service: we keep intended use current, classify work, draft change and release assessments, and support administration under your change-control SOP. Your Vault owner still approves what goes to production.
Computer system validation (CSV) and computer software assurance (CSA) are how you prove a GxP system is fit for intended use. CSA asks you to think: which functions can harm a subject or the data, and what assurance is already available from the vendor? CliniGene uses AI to draft intended use, risk scenarios, and test ideas from your manuals and SOPs. Your CSA owner decides the official mix of scripted tests, unscripted assurance, and vendor evidence.
Vendor qualification is a file you can hand an inspector: questionnaire, quality agreement, audit or desktop review, CAPAs, certificates, and the last periodic review. CliniGene uses AI to inventory what arrived, map answers to your SOP and Part 11/Annex 11 expectations, and flag contradictions. The qualification decision is always a person.
Inspectors read your SOP and then watch the process. If those two stories differ, you have a finding. CliniGene develops controlled documents from interviews and the real system, not from a generic template dump. AI produces the structured first draft and a cross-SOP conflict list. Your process owner and QA revise; document control makes it effective.
eTMF quality is not a green dashboard. It is whether the artifact that should exist for this milestone exists, is the right version, is identifiable to the study/site, and would survive an inspector reading it. CliniGene uses AI to pre-score inventory and documents. TMF specialists perform official QC and decide what is a miss vs. an allowed lag.
Inspection readiness is whether people and documents tell the same story under time pressure. CliniGene assembles the narrative and the war-room index with AI, then runs mock front-room / back-room drills. Findings are written by reviewers who have sat in those rooms. We do not invent a regulatory opinion or predict a 483.
Email hello@clini-gene.com or use the form. Include the service number.