Resources

Focused starting points

Two bounded offers for teams that need a documented next step — not a large consulting program.

AI and GxP Readiness Assessment

Understand where AI is already being used, which use cases may affect GxP activities, what regulatory and data risks require attention, whether existing governance is sufficient, which AI opportunities offer meaningful business value, and what should be implemented during the next 90 days.

Deliverables include an AI-use inventory, GxP-impact classification, risk and compliance gap assessment, AI-governance recommendations, prioritized use-case portfolio, executive summary, and a practical 90-day roadmap.

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Five-Day GxP Change Assessment

Planning a Veeva, eQMS, eTMF, CTMS, LMS, or other regulated-system change? CliniGene evaluates the proposed change and provides a documented validation recommendation.

You receive a concise, review-ready assessment that Quality, Business, and Technology stakeholders can use to determine the appropriate implementation and validation path — including recommended deliverables, verification scenarios, an initial effort estimate, and a fixed-fee execution proposal.

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