DATAN Analytics AI+

DATAN Analytics AI+ is a browser-based platform developed by DATAN Analytics GmbH that automates statistical and data management tasks across the clinical trial lifecycle. Core use cases include SAP generation from study protocols, SAS code generation for SDTM-to-ADaM conversion, TFL programming, and Clinical Study Report drafting.

The platform uses customizable AI agents trained on client-specific templates and SOPs. Once configured, users upload the relevant input, initiate the workflow, and receive the output for human review and sign-off — no coding required. Agent development is done in close collaboration with the client; a free proof-of-concept based on a client use case is offered as the entry point. Onboarding takes up to two weeks after PoC completion.

Primary users are biostatisticians, clinical data managers, and statistical programmers at CROs, pharma sponsors, and biotech companies running regulated trials. The platform is designed for organizations with sufficient work volume to benefit from workflow automation.

On the compliance side: servers are ISO 27001-certified, LLMs are EU-hosted and GDPR-compliant, access is controlled via VPN or fixed IP with two-factor authentication, and the platform includes a full audit trail. 21 CFR Part 11 readiness is supported.

Reported cycle time reductions reach up to 80% — with SAP generation moving from days to hours as the flagship example.