01
Structured SAP authoring
Author the analysis plan as structured content , populations, estimands, endpoints, and analyses , rather than free text.
CLYMBR HUB · SAPSAP Builder ™
Turn Statistical Analysis Plans into structured, machine-readable metadata.
SAP Builder transforms how teams create, manage, and govern Statistical Analysis Plans. AI-assisted authoring converts SAP requirements into structured metadata that flows directly into TFL Designer, eliminating ambiguity and accelerating downstream programming with full traceability from protocol to final outputs.
- Structured, machine-readable SAP metadata
- AI-assisted content generation
- Reusable templates and standards
- Direct hand-off to TFL Designer
SAP Builder , in the workflow— / 03
upstream
Protocol objectives, endpoints, and CRF design provide the inputs SAP Builder reasons over.
80% Reduction in SAP Authoring Time
Structured, template-driven SAP authoring, review, and approval
Automatic TFL Shell Generation
AI Assisted TFL Shell Auto-generation from Study SAP
Intuitive SAP Library
Create your sponsor specific SAP library in our GxP compliant system
Capabilities
What SAP Builder does
SAP Builder turns the analysis plan into an asset the rest of the platform can execute against, not a document to re-interpret.
02
AI-assisted drafting and review
Draft sections from the protocol and prior SAPs, and check the plan for internal consistency before circulation.
03
Analysis Concept & ARS alignment
Analyses are captured as CDISC Analysis Concepts that map cleanly to the Analysis Results Standard.
04
Sponsor templates and standards
Encode your own SAP templates, conventions, and boilerplate once and reuse them across the portfolio.
05
Review, versioning and approval
Comment, redline, version, and electronically approve the SAP and its amendments inside the SCE.
06
Direct hand-off to TFL Designer
Approved analyses flow into TFL Designer so shells and code are generated from the plan itself.
How it works
SAP Builder in the workflow
From protocol to approved analysis metadata, with the hand-off to TFL Designer built in.
Start from the protocol
Import protocol content and sponsor templates to seed objectives, endpoints, and populations.
Define the analyses
Capture each analysis as structured metadata: population, parameter, method, and display.
Review and approve
Circulate for comment, resolve redlines, and sign off with an auditable electronic signature.
Push to TFL Designer
Approved analysis metadata generates the TFL shell set and downstream code specifications.
Key functionalities
Everything included in SAP Builder
SAP Builder is an AI-powered module that turns protocol inputs and study requirements into structured, standardized Statistical Analysis Plans , then hands the metadata straight to TFL Designer.
11 capabilities shipped today
Capability
Secure cloud-based, scalable solution
Select any capability to see what it does.
Standards & compliance
Built to the standards your submission expects
- ICH E9 / E9(R1)
- CDISC AC/DC
- CDISC ARS
- CDISC ADaM
- 21 CFR Part 11
Who uses it
Teams working in the same workspace
- Biostatisticians
- Biostatistics leads
- Statistical programmers
- Medical writers
- Regulatory affairs
Common questions
About SAP Builder
What problem does SAP Builder solve?+
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.
How does AI assist in SAP authoring?+
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.
Does SAP Builder integrate with TFL Designer?+
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.
See SAP Builder inside Clymbr Hub.
Bring your team, your study, and your code. We'll show you SAP Builder working end-to-end alongside the rest of the platform.