Clinical Statistical Workflow
From research questions to reviewable delivery.
Clinical statistics connects evidence, decisions, data standards, specifications, programs, validation, and review. AI supports how these parts are organized and carried forward, while professional roles shape judgment, interpretation, and approval.
01 · Business Workflow
Clinical statistical delivery
Each stage carries professional decisions into a defined artifact, review point, and downstream dependency.
- 01
Protocol
- Decision
- Interpret objectives, endpoints, populations, visits, estimands, and study constraints.
- Artifact
- Traceable requirements and questions requiring confirmation.
- AI and system support
- Locate relevant statements, connect sources, and surface gaps or inconsistencies.
- Professional judgment
- Confirm the clinical question and its statistical interpretation.
- 02
Statistical strategy / SAP
- Decision
- Define estimands, analysis sets, methods, intercurrent events, missing data, multiplicity, and sensitivity analyses.
- Artifact
- Statistical decisions, SAP content, and analysis specifications.
- AI and system support
- Retrieve applicable knowledge, organize possible approaches, and check Protocol/SAP consistency.
- Professional judgment
- Select methods, resolve assumptions, and approve the statistical strategy.
- 03
SDTM
- Decision
- Define source mappings, domains, controlled terminology, timing, and traceability.
- Artifact
- SDTM specifications, datasets, and validation findings.
- AI and system support
- Propose mappings, apply repeatable rules, and organize exceptions for review.
- Professional judgment
- Confirm mapping exceptions and interpretations of data standards.
- 04
ADaM
- Decision
- Define analysis populations, parameters, derivations, baselines, and analysis time points.
- Artifact
- ADaM specifications, datasets, and traceability to SDTM and SAP decisions.
- AI and system support
- Translate approved decisions into structured derivations and check consistency.
- Professional judgment
- Confirm analysis meaning, derivation rules, and fit for statistical use.
- 05
TFL
- Decision
- Define displays, statistical calculations, shells, programs, and output structure.
- Artifact
- TFL shells, programs, tables, listings, figures, and results.
- AI and system support
- Turn specifications into clear, repeatable tasks and check the expected structure.
- Professional judgment
- Review statistical interpretation, program logic, and output presentation.
- 06
QC / Review
- Decision
- Reconcile data, programs, results, versions, and independent findings.
- Artifact
- QC evidence, differences, review records, and resolved decisions.
- AI and system support
- Run repeatable validation, locate differences, and assemble review context.
- Professional judgment
- Perform independent QC and determine whether findings are resolved.
- 07
Submission
- Decision
- Confirm completeness, consistency, version identity, and delivery readiness.
- Artifact
- Reproducible, traceable, and reviewable delivery materials.
- AI and system support
- Assemble validation and traceability evidence across the delivery package.
- Professional judgment
- Approve the formal delivery and its supporting evidence.
02 · AI Workflow
AI-supported work across the delivery path
AI assists retrieval, organization, transformation, execution, and checks, while professional roles complete statistical judgment, interpretation, and approval.
- 01Knowledge context
- 02Statistical decision
- 03Structured specification
- 04Assisted execution
- 05Validation
- 06Human review
- 07Traceable delivery
03 · Product 01
Clinical Knowledge Wiki
RAG & Vector Knowledge Base
A traceable knowledge system for organizing guidelines, standards, study documents, and professional experience into content that can be retrieved, checked, and reused.
- 01Sources
- 02Evidence
- 03Knowledge structure
- 04RAG & vector retrieval
- 05Human review
- 06Versioned knowledge
AI and system support
- Locate evidence in long documents and preserve relevant context.
- Connect related concepts, terminology, and semantic matches.
- Organize key summaries, differences, conflicts, and knowledge needs.
Professional judgment
- Decide whether a source and interpretation apply to the current context.
- Resolve conflicts, review knowledge content, and approve formal versions.
Current capabilities
- Organized sources, evidence, knowledge entries, versions, and relations.
- Document preparation and traceable evidence locations.
- Knowledge entries and a professional review workspace.
Next workflow
- Wiki-based knowledge organization with keyword, semantic, and vector retrieval.
- Complete professional review and versioned knowledge publication.
- Reviewed, traceable knowledge context for Clinical Workflow.
04 · Product 02
Clinical Workflow
Statistical Delivery Workflow
A clinical statistical delivery workflow connecting study requirements, statistical decisions, data standards, analysis specifications, program outputs, and quality review.
- 01Protocol
- 02Statistical strategy / SAP
- 03SDTM
- 04ADaM
- 05TFL
- 06QC / Review
- 07Submission
AI and system support
- Organize requirements and retrieve reviewed knowledge context.
- Translate confirmed decisions into structured specifications and repeatable tasks.
- Support consistency checks, validation, and review preparation.
Professional judgment
- Interpret the study and decide estimands, populations, methods, exceptions, and derivations.
- Review program logic and results, perform independent QC, and approve delivery.
Current capabilities
- Fixed clinical stages and explicit business dependencies.
- Action selection, review records, and knowledge-version references.
- Study materials, representative deliverable flows, and change records.
Next workflow
- A continuous record connecting decisions, specifications, execution, and artifacts.
- Stage-based execution connecting validation, professional review, and formal delivery.
- Knowledge-version references, identified knowledge needs, and review feedback.
05 · Architecture
Two products connected by traceable context
The knowledge product and the delivery workflow retain separate responsibilities while exchanging versioned context and review feedback.
→ Reviewed, versioned knowledge context with sources and applicability
← Knowledge needs, differences, and review feedback requiring professional assessment
06 · Governance
Professional judgment, system support, and approval form a responsibility chain
The system makes repeated work more consistent, while professional roles carry the corresponding responsibilities for statistical interpretation, quality review, and formal approval.
- Professional roles
- Clinical interpretation, statistical methods, assumptions, exceptions, independent review, risk acceptance, and final approval.
- Knowledge product
- Sources, evidence, knowledge structure, retrieval context, review state, and versioned knowledge.
- Clinical workflow
- Business stages, decisions, specifications, artifacts, validation state, review, and delivery traceability.
- AI support
- Retrieval, organization, approach preparation, transformation, assisted execution, consistency checks, and review preparation.
07 · Projects
Existing product foundations
The current project cases document the evidence, workflow capabilities, and next direction for each product.
Workflow Insights
Related insights
Focused accounts connected to the workflow stages shown above.
Reviewed
From protocol to SAP: making statistical decisions executable
The protocol defines the scientific question; the SAP must turn it into analysis choices that can be reviewed before programming begins.
Reviewed
From SDTM and ADaM to TFL: what automation changes
Automation is most useful when specifications, programs, validation, review, and release form one controlled delivery chain.
Reviewed
From document retrieval to reusable knowledge
Source evidence, professional interpretation, review records, and knowledge versions connect document retrieval to the clinical workflow.