Get CDISC off repeat. From raw study to submission ready in days.

Clinical data coding agents that turn raw study data into SAS® programs, SDTM, ADaM and TLFs—with full traceability.

Built on OpenSAS, the open-source SAS® runtime developed by KIRHA.

  • SOC 2 Type I
  • ISO 27001
  • HIPAA / HDS

A new era for clinical data programming. With you in the driver’s seat.

Talk with your study data. Discover SDTM mappings and ADaM derivations. Generate SAS programs following your coding conventions.

Automation you can defend in an audit

AI speed without compromising quality or security. The audit trail builds itself as the work happens, eliminating hours of manual reconstruction.

Equivalent

Reproducible by design

OpenSAS is tested against SAS® documentation, producing byte-for-byte equivalent outputs for supported programs.

Persistent

Audit-ready

Every programming session, code execution, and output is preserved in your environment.

Sovereign

Your environment

The agent runs in your VPC, on premises, or on KIRHA HDS / HIPAA-certified infrastructure.

Open and Community Driven

Built with CROs, for CROs. The agent was designed alongside teams who live inside real submissions, and runs on OpenSAS, the open-source SAS runtime (Apache 2.0) developed by KIRHA.

829unit tests
1865case corpus
2submitted studies

Tested on PhUSE synthetic datasets

Conformance-suite facts, not performance claims. Reproduce them yourself from the open benchmark.

More questions? More answers

No. KIRHA independently develops and maintains OpenSAS and is not affiliated with or endorsed by SAS Institute Inc. SAS and all other SAS Institute Inc. product or service names are registered trademarks or trademarks of SAS Institute Inc. in the USA and other countries. ® indicates USA registration.

No. The agent produces readable SAS programs that your team can inspect, edit, and approve. Every execution is recorded with its inputs, outputs, errors, and corrections. You review the code and evidence behind each dataset, not just a model-generated answer.

KIRHA can be deployed in your VPC, on premises, or on HDS-certified infrastructure. Data residency, model access, retention, and subprocessors are defined according to your deployment and documented in the DPA and security documentation. Your SAS programs, datasets, and execution records remain portable and under your control.

KIRHA provides the audit trails, reproducible executions, access controls, and review steps needed to support validation. Every output remains subject to human approval. Part 11 compliance depends on the configuration of the complete system and your operating procedures, so KIRHA supports your validation process rather than claiming that every deployment is automatically compliant.

They serve complementary roles. KIRHA generates and executes the programs that produce SDTM datasets, while Pinnacle 21 checks those datasets for standards conformance. You can keep Pinnacle 21 as an independent validation layer within your existing workflow.

Try it on your next study

Tell us about your workflow and compliance constraints. We'll get back to you within one business day.

  • SOC 2 Type I
  • ISO 27001
  • HIPAA / HDS

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