Sovereign AI for Regulated Workflows
Own your models. Protect your data. Trace every decision.
SOC 2 Type I
ISO 27001
HIPAA / HDS
Trusted by accountable teams in high-stakes environments
AI agents in Healthcare and Life Sciences
Where every decision matters, every byte is regulated, and every action must be defensible.
Pharma Regulatory
Regulatory intelligence with Vidal, EMA, EUR-Lex, ANSM and national registers. Fill your Signal Report and SOP, RMP and PSUR templates. Designed with PV and Regulatory Affairs veterans.
- Market authorisations tracked across EU and national registers
- Sourced answers your compliance team can audit
- Weekly manual reviews replaced by continuous monitoring
Clinical Trials Data Programming
Generate submission-ready CDISC datasets and SAS programs from clinical trial specifications in hours, not weeks. Powered by OpenSAS, our open-source SAS toolchain. Designed with eXYSTAT, a CRO with more than a decade of clinical programming experience.
- CDISC Datasets, TLFs and validation programs
- Agentic double programming
- Full audit trail from spec to output
Clinical Evidence
Auditable Clinical Decision Support for medical teams developed with Cureety. KIRHA Search covers PubMed, HAS, NCCN, NIH and trial registries with provenance on every result.
- Continuous evidence watch across medical guidelines and literature
- Structured summaries with citations attached
- Built for clinical teams with a leader in patient monitoring
Pharmacovigilance
Monitor adverse events across FDA FAERS, EudraVigilance and the published literature. Signals are surfaced, triaged and documented, with PRR and ROR scores computed in minutes and every source traceable for audit.
- Continuous signal detection across safety databases
- Case triage with sourced supporting evidence
- Audit-ready documentation for every signal
From intent to production system
Models trained on your proprietary data. Context engineered for your use cases. Deployment aligned with your security and compliance requirements.
Scoping call
A 30 minute call to define success, map your workflow and identify your compliance constraints.
Pilot on your data
Custom context for your agents. Optional evals and fine tuning. Measure against your current workflow.
Production with audit trails
The agent ships on certified infrastructure. Every run is logged, sourced and traceable.
KIRHA agents run on certified infrastructure
Your data remains inside compliant environments end to end.
Independently audited controls for security and availability.
Certified information security management system.
Certified hosting for French health data.
Personal data handled under EU regulation.
Turn regulatory hurdles into an unfair advantage
Show us your workflow. We’ll show you what’s possible.