Survey
Identify current AI use, business needs, workflows, data sources, systems, risks, and compliance obligations.
Our Approach
The CliniGene SAFE-AI Approach
A bounded path from inventory to continued suitability — so AI supports regulated work without taking approval authority away from your people.
Architect
Define intended uses, responsibilities, risk classifications, human-review requirements, policies, and procedural controls.
Fortify
Assess vendors, protect regulated information, establish traceability, and develop proportionate validation evidence.
Execute
Implement a bounded use case, conduct testing, train users, document limitations, and obtain required approvals.
Assure
Monitor output quality, incidents, model or vendor changes, user behavior, and continued suitability for intended use.
Improve
Measure results, address lessons learned, and expand only those use cases that demonstrate acceptable performance and business value.
Human Oversight Is Built Into Every Engagement
CliniGene follows a simple operating principle:
AI may assist with preparation, analysis, comparison, summarization, and consistency checks. Humans remain accountable for regulated decisions and approvals.
AI will not independently:
- Approve or close quality records
- Approve CAPAs
- Make product-disposition decisions
- Determine patient eligibility
- Provide medical judgment
- Replace sponsor, investigator, or Quality approval
- Determine regulatory compliance without expert review
Talk through SAFE-AI on your use case
Start with an AI and GxP Readiness Assessment, or tell us the system and process already in motion.