Start from approved sources
Bring together the protocol, endpoints, study design, and sponsor standards as a documented foundation for the plan.
NARRATIVA · BIOSTATISTICS
Statistical Analysis Plan with AI Agents
Help biostatistics teams develop clear, protocol-aligned Statistical Analysis Plans—with source-aware drafting, consistency checks, and expert review at every step.
AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS
BIOSTAT DEVELOPER · SAP WORKFLOW
Define. Document.
Review with rigor.
Purpose-built agents help biostatistics teams turn approved study inputs into a structured analysis plan, surface potential gaps, and coordinate review—while qualified statisticians retain control of the methodology and final decisions.
Clarify the objectives
Organize objectives, endpoints, estimands, and analysis populations so the plan reflects the intent of the study.
Structure the methods
Draft plan sections for primary and secondary analyses, multiplicity, missing data, and sensitivity analyses for expert input.
Check consistency
Compare the draft with source documents to flag misalignment, missing detail, and decisions that need confirmation.
Manage review and versions
Keep changes, comments, and decisions connected through review cycles and controlled document updates.
Keep decisions with experts
Biostatisticians assess the scientific rationale, assumptions, and methods, and approve the plan before it guides analyses.
BIOSTAT DEVELOPER · CLINICAL STUDY DESIGN
Make the analysis strategy explicit before the data is unblinded.
A Statistical Analysis Plan (SAP) describes how a clinical study’s data will be analyzed. It expands on the protocol by defining analysis sets, endpoints, estimands, statistical methods, handling of intercurrent events and missing data, multiplicity, and planned sensitivity or subgroup analyses.
BioStat Developer helps teams organize source information into a structured draft, surface decisions that need clarification, and check plan content against the protocol and study conventions. Biostatisticians remain accountable for the scientific rationale, methodological choices, and approval of the final SAP.
STATISTICAL ANALYSIS PLANS · FAQ
Rigorous plans, with experts in control.
Learn how AI-assisted workflows can support statistical analysis plan development and review.
What is a Statistical Analysis Plan?
A Statistical Analysis Plan (SAP) describes the planned analyses for a clinical study. It typically details analysis populations, endpoints, estimands, statistical methods, missing-data approaches, multiplicity, and planned sensitivity or subgroup analyses. It provides a prespecified framework for conducting and reporting the study analyses.
How can AI agents support SAP authoring?
AI agents can help organize approved study inputs, draft structured sections, identify missing or inconsistent details, and support comparison with protocols and templates. Biostatisticians and study experts review and determine the final content.
How does the workflow help align a plan with the protocol?
Source-aware checks can compare objectives, endpoints, study populations, visit schedules, and other key details between the SAP draft and approved study documents. Potential discrepancies and decisions requiring clarification can be surfaced for expert review.
Can AI choose the statistical methods for a study?
AI may help organize candidate methods or draft descriptions based on supplied study context, but it does not replace statistical judgment. Qualified biostatisticians evaluate whether methods, assumptions, estimands, and sensitivity analyses are scientifically appropriate for the study.
When should the SAP be finalized?
The SAP should be completed and approved according to the study’s governance and applicable guidance, typically before unblinding or access to treatment assignments for the analyses it prespecifies. Teams should follow their protocols, procedures, and regulatory requirements.
How are updates and review decisions tracked?
Controlled authoring workflows can keep reviewer feedback, document versions, source references, and change decisions together. Teams apply their established approval processes to ensure the current SAP version is clear and authorized for use.