Services / GCP & audit readiness
GCP & audit readinessGCP 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.
Most teams do not fail GCP because they lack SOPs. They fail because evidence is incomplete, late, filed in the wrong place, or inconsistent with the protocol amendment that was in force on the visit date. Manual sampling finds some of that. It does not systematically walk every ICH-GCP E6 expectation against every required artifact for the trials you name.
Before an audit, QA is asked to “make sure we are ready” with a few weeks of calendar and a TMF that grew for years. The first questions an auditor asks — informed consent, investigator qualifications, protocol deviations, monitoring, investigational product, safety reporting — are predictable. The answers are scattered across eTMF, CTMS, EDC, safety, and email.
AI does not replace the quality unit. It makes the first reconciliation fast enough that specialists spend time on significance, CAPA, and the story you will tell in the front room.
An auditor asks how you know consent, monitoring, and deviations match the protocol in force on the visit date. You should be able to open a clause row, point to the artifact, and explain gaps that are still open — with a person who signed the finding, not a model.
Sponsor and CRO quality, clinical operations, study leads, and site-oversight teams preparing for a sponsor audit, CRO oversight review, or health-authority inspection.
On GCP work, AI builds the first clause-to-artifact map, date-collision list, and CAPA draft language from the trial pack you name. A GCP specialist issues the official findings and classifications. AI drafts maps, flags, first-pass language, and punch lists. A named specialist accepts, edits, or dismisses every official finding. AI does not sign a quality record, approve a vendor, freeze Vault, or speak in an inspection.
Questions on fit? hello@clini-gene.com or the contact form.
Start 6–10 weeks before a planned sponsor audit or when TMF completeness is a percentage with no clause map. Also start after a for-cause event (consent, IP, SAE) when you need a systematic file, not a scramble.
Do not wait until the auditor’s agenda arrives. The useful product is a matrix you can close against, not a slide the week of.
Each layer has a human gate. AI does not write the official quality record.
We only index the trial(s), SOP set, and systems you name. The model is instructed to judge against those sources, not against generic internet GCP text. Out-of-scope studies are excluded so findings cannot be invented from another program.
Each selected ICH-GCP clause and SOP requirement is paired with the TMF artifact type (or CTMS/EDC record) that would satisfy it. AI lists present, weak, missing, or wrong-version evidence and points to the expected zone/section in your TMF plan.
Consent, amendment, monitoring visit, and deviation dates are checked against each other. A common finding is a visit conducted under the previous protocol without a documented waiver — AI flags the date collision; a person decides if it is a true deviation.
The same gap at many sites (late monitoring report, unsigned DoA, missing temperature log) is grouped so you fix the process, not only the file. Specialists set severity and whether it is systemic.
AI drafts finding text, likely root-cause prompts, and suggested evidence to attach on close. QA assigns owner, due date, and classification. Nothing enters the official CAPA system until a person pastes and signs.
Send the study, Vault, vendor, or inspection window. We will say what we need and what a first pass looks like.
Agree which trial(s), which sites if any, which systems (eTMF, CTMS, EDC, safety, IRT), and whether this is a sponsor audit, CRO oversight, for-cause, or inspection prep. Write what “ready” means in one paragraph so the AI is not given a wandering brief.
Protocol family, TMF plan and index, SOP list with effective dates, monitoring plan, CAPA log, and exports you can legally share. We work in a restricted workspace. We do not use your files to train public models.
AI extracts enforceable requirements from ICH-GCP and your SOPs (not guidance fluff). The specialist edits the library — this is the checklist the rest of the work is scored against.
Inventory extract vs. requirement library. Each row is present / weak / missing / not applicable, with a pointer. Weak means the artifact exists but is unsigned, wrong version, or does not cover the date range.
Every AI-suggested finding is accepted, merged, rewritten, or dismissed. Dismissals are kept so you can show an inspector the machine was not the decision-maker.
Patient safety, data integrity, and inspection visibility. High-visibility items (consent, IP, SAE reporting, investigator oversight) are called out even when the TMF “completeness %” looks fine.
Clause-to-evidence matrix, finding register with reviewer name, CAPA drafts, and a briefing: the ten questions an auditor will ask first and where the answer lives.
When you upload the new artifact, AI re-runs only those rows. Closed means new evidence, not a status flip.
Setting. Typical: one Phase 2/3 study, 20–40 sites, eTMF + CTMS export, 4–6 weeks to a planned sponsor audit.
What we do. AI maps GCP clauses and the TMF plan to the inventory, flags consent/amendment date collisions and open monitoring actions, and clusters site-repeat issues. QA confirms findings and issues a CAPA register plus a one-day briefing book.
What you can show. You walk into the audit with a clause-level map and evidence for what was closed — not a slide that says “TMF 94% complete.”
A single-study readiness pass is usually 3–6 weeks depending on export quality and how many sites you include. A platform-level GCP system review (SOPs + several studies) is scoped as a separate program.
Email hello@clini-gene.com or use the form. Mention GCP compliance and audit readiness so we route it correctly.
Email hello@clini-gene.com or send this form. The process is already selected.
Tell us the trial, Vault, vendor, or inspection date and what “done” looks like.
Email hello@clini-gene.com if you prefer not to use the form.
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Apply GAMP 5 and FDA computer software assurance so testing follows patient-safety and data-integrity risk — not a copy-paste IQ/OQ/PQ for every screen.
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Build and keep a risk-based qualification file for CROs, labs, IRT/EDC/eTMF vendors, and GxP cloud — AI compares answers to your SOP; QA decides approve or reject.
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Write SOPs, work instructions, forms, validation plans, and reports that match the process people actually run — AI first draft, owner and QA edit, document control publishes.
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Reconcile the electronic TMF to the TMF plan and milestones — completeness, QC, and inspectability — with AI pre-checks and TMF specialists issuing the official metric.
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Run a scored mock: narrative, war-room index, interviews, and a 30-day closeout plan — AI builds the pack; experienced reviewers run the room.
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