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Clinical Quality

Clinical Quality and Compliance

CliniGene helps sponsors and CROs strengthen clinical quality, documentation, and oversight.

Schedule a Consultation Email hello@clini-gene.com

CliniGene helps sponsors and CROs strengthen clinical quality, documentation, and oversight.

CliniGene does not replace medical judgment, investigator responsibilities, sponsor oversight, or required regulatory approvals.

CliniGene does not replace medical judgment, investigator responsibilities, sponsor oversight, or required regulatory approvals.

Services Include

  • Clinical Quality Management System support
  • ICH GCP gap assessments
  • ICH E6(R3) readiness
  • eTMF completeness and quality reviews
  • Essential-document reconciliation
  • Sponsor and CRO oversight
  • Vendor qualification
  • Protocol-deviation trending
  • CAPA support
  • Clinical-system validation
  • Mock inspection support
  • Inspection-readiness planning
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How we take this further

GCP 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.

eTMF percentages hide empty placeholders. Vendor files die in email. Inspection rooms fail when people and documents tell different stories. CliniGene strengthens sponsor oversight, clinical documentation, eTMF readiness, vendor management, and GCP compliance — with specialists issuing official findings.

Standards we score against

  • ICH-GCP E6(R2) and E6(R3) principles and sponsor/investigator duties
  • Protocol, IB, and amendments in force by visit date
  • TMF Reference Model (or your sponsor index) and your TMF plan
  • Your GCP, monitoring, TMF, deviation, training, and vendor SOPs
  • 21 CFR 312 / 812 and applicable local requirements when in scope

Where teams get stuck

  • TMF completeness reported as a percentage with no essential-document reconciliation
  • ICH E6(R3) readiness treated as a rename of the old SOP set
  • Sponsor oversight of the CRO that cannot be shown in a file
  • Vendor qualification that will not survive a pick-one-vendor test
  • No war-room index before a plausible inspection window

Who it is for

Sponsor and CRO quality, clinical operations, TMF managers, study leads, and inspection-prep teams preparing for sponsor audit, CRO oversight review, or health-authority inspection.

What AI does — and does not do

AI supports analysis, consistency, traceability, and document preparation. Qualified professionals review every regulated deliverable, and customers retain final approval authority. AI-generated content remains a draft until it has been reviewed and approved by an authorized individual.

Questions on fit? hello@clini-gene.com or the contact form.

AI in this process

How the model is used, layer by layer

Each layer has a human gate. AI does not write the official quality record.

Clause-to-artifact mapping

Selected ICH-GCP expectations and SOP requirements are paired with the TMF or CTMS artifact that would satisfy them.

Expected vs. actual eTMF

From the TMF plan and milestone, AI reconciles inventory. Placeholders are separated from collected.

Deviation and CAPA themes

Protocol deviations and open CAPAs are clustered so you fix the process, not only the row.

Inspection question-to-path

Likely questions paired with artifact paths. Missing path = readiness gap.

Want this process walked on your trial or system?

Send the study, Vault, vendor, or inspection window. We will say what we need and what a first pass looks like.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com
End-to-end process

Step-by-step: from intake to re-check

  1. 1

    Define the clinical-quality question

    Study, systems, whether this is GCP gap, E6(R3) readiness, eTMF, vendor, mock inspection, or a combination.

  2. 2

    Collect the controlled pack

    Protocol family, TMF plan, SOP list, monitoring and CAPA logs, vendor list, prior findings.

  3. 3

    Assess GCP and E6(R3)

    Gap assessment against ICH GCP and your procedures, including what R3 changes for your operating model.

  4. 4

    Reconcile essential documents and eTMF

    Completeness, QC, and inspectability — official QC is human.

  5. 5

    Review sponsor/CRO oversight and vendors

    Oversight evidence, qualification files, subcontractors.

  6. 6

    Trend deviations and support CAPA

    Themes, owners, effectiveness — classification stays with Quality.

  7. 7

    Validate clinical systems when in scope

    Intended use and proportionate evidence; details sit with CSV/CSA when the system is the object.

  8. 8

    Plan or run inspection readiness

    Narrative, war-room index, mock support, 30-day closeout. We do not predict a 483.

What a typical engagement looks like

Setting. Typical: one Phase 2/3 study, eTMF in Vault or another system, CRO in place, inspection or sponsor audit possible in a quarter.

What we do. GCP / E6(R3) view, eTMF reconcile, vendor file check, deviation themes, and an inspection-readiness plan or mock.

What you can show. You can show oversight, the file, and the story — without CliniGene replacing sponsor, investigator, or medical judgment.

Time

A single-study GCP and eTMF pass is often 3–8 weeks. Inspection-readiness with a mock is commonly 4–8 weeks. Ongoing clinical-quality support can be monthly or per milestone.

What we need from you

  • Protocol, IB, and amendments with effective dates
  • TMF plan, index, and inventory export
  • Monitoring, deviation, CAPA, and training logs
  • Vendor list and existing qualification files
  • Inspection SOP and who may speak, if mock or readiness is in scope

You receive

  • Clinical QMS support and ICH GCP / E6(R3) gap assessments
  • eTMF completeness and quality reviews
  • Essential-document reconciliation
  • Sponsor and CRO oversight support
  • Vendor qualification support
  • Protocol-deviation trending and CAPA support
  • Clinical-system validation support
  • Mock inspection support and inspection-readiness planning

Questions we hear first

Do you replace the TMF manager or Quality unit?
No. We add review, maps, and punch lists. Your owners still own the vault and the QMS.
Will you tell us we will pass inspection?
No. We score readiness and list gaps. Inspection outcomes are not something we predict or guarantee.

Start with Clinical Quality and Compliance

Email hello@clini-gene.com or use the form. Mention Clinical Quality and Compliance so we route it correctly.

hello@clini-gene.com

Schedule a Consultation Email hello@clini-gene.com

Talk with us about Clinical Quality and Compliance

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.

Contact Form

Email hello@clini-gene.com if you prefer not to use the form.

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