SAP Builder

SAP Builder accelerates the creation, standardisation, and maintenance of Statistical Analysis Plans (SAPs) for clinical trials. Built as an extension of TFL Designer and integrated across the Clymb automation suite, SAP Builder helps biostatistics teams move from protocol and CRF to a review-ready SAP- faster, more consistently, and with better traceability.

  • Protocol & CRF-Driven Drafting

    Automatically structures core SAP sections using protocol objectives, estimands, endpoints, visit schedules, and CRF design—reducing manual copy/paste and ensuring alignment from day one.

    Protocol & CRF-Driven Drafting
  • Analysis Concepts Library

    Select from a curated set of analysis concepts (e.g., Change from Baseline, Time-to-Event, Responder Analysis) to instantly populate consistent methods language, assumptions, and parameter definitions—tailored to your study.

    Export & Downstream Integration
  • Intelligent Section Builder

    Generate and refine subsections with guided prompts and configurable standards (sponsor style, therapeutic area norms, SAP templates), ensuring consistency across programs while still allowing full expert control.

    Traceability & Version Control
  • Traceability & Version Control

    Track what changed, when, and why—across drafts, amendments, and final SAPs. Compare versions side-by-side, restore prior iterations, and maintain clear linkage back to protocol/CRF inputs for faster review cycles.

    Intelligent Section Builder
  • Export & Downstream Integration

    Export SAPs to Word or PDF for distribution and submission workflows, and connect directly to TFL Designer to help ensure planned analyses translate cleanly into table, figure, and listing shells—reducing handoff friction and downstream rework.

    Analysis Concepts Library
Protocol & CRF-Driven Drafting
Export & Downstream Integration
Traceability & Version Control
Intelligent Section Builder
Analysis Concepts Library

Why SAP Builder?

SAP Builder is a web-based solution that helps teams generate, refine, and govern SAPs with consistency and speed. By leveraging protocol and CRF inputs-plus reusable analysis standards-SAP Builder makes it easier to produce high-quality SAPs that are aligned, reviewable, and ready for downstream execution.

  • 75%

    Reduction in overall SAP authoring time

  • ICH E9 and Transcelerate eSAP aligned

  • 50%

    Reduction in rework across SAP versions and ammendments

Experience the power of SAP Builder

Contact the Clymb team to schedule a demo of our SAP Builder solution and learn more about our community and enterprise-level offerings.