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.
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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.
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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.
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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.
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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.
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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.
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.
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75%
Reduction in overall SAP authoring time
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ICH E9 and Transcelerate eSAP aligned
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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.