SAP Builder ™

AI-assisted SAP authoring uses machine learning to draft Statistical Analysis Plan sections from the protocol, prior SAPs, and study metadata. It suggests analysis objectives, endpoints, estimands, populations, and derivations, then lets biostatisticians review and approve every element. The result is a structured, reusable SAP rather than a static Word document.

SAP Builder captures analyses as CDISC Analysis Concepts and Analysis Results Standard (ARS) metadata. Populations, parameters, methods, and displays are stored in a governed structure that maps cleanly to CDISC ADaM datasets and TFL shells, so the plan, datasets, and outputs stay synchronized.

Yes. SAP Builder includes templates and structured fields for ICH E9(R1) estimand components — population, treatment, variable, and intercurrent events — so sponsors can build estimand-aligned analysis plans consistently across studies.

Traditional SAPs are unstructured Word documents that programmers must re-interpret. SAP Builder captures the SAP as structured, machine-readable metadata so downstream tools like TFL Designer can consume it directly, removing ambiguity and rework.

SAP Builder uses AI to draft sections from your protocol and prior SAPs, suggest analysis populations and derivations, and check consistency across the plan. Authors remain in control; the AI accelerates drafting without replacing statistician judgment.

Yes. Analyses defined in SAP Builder flow directly into TFL Designer so the mock-ups, shells, and code you generate stay aligned with the approved plan.

Yes. SAP Builder lets you encode sponsor-specific templates, analysis libraries, and therapeutic-area standards once, then reuse them across the portfolio. Version control and approval workflows keep standards governed.

Yes. SAP Builder runs in a GxP-aligned environment with threaded review comments, version history, diffing, and 21 CFR Part 11 electronic signatures, creating an audit trail for every change.