Standards management
Track SDTM and ADaM specifications, variables, derivations, terminology, and versions.
Portfolio project · Synthetic data
CLINICAL DATA WORKFLOW PLATFORM
Clinical data, engineered for confident decisions.
An interactive platform concept connecting clinical-data standards, statistical programming, traceability, validation, and submission readiness in one clear workflow.
Demonstration environment. No patient-level or confidential data.
Submission ReadinessValidated deliverables
DATASETS24
TLFs86
FINDINGS4
READY94%
WORKFLOW STATUS
✓✓✓✓94
READINESS
94%
9Connected workflow modules
3Synthetic demonstration studies
SDTM · ADaMStandards-centered architecture
Desktop + MobileResponsive demonstration access
PROJECT OVERVIEW
From source data to submission readiness.
The concept reduces fragmented oversight by bringing specifications, programming, quality review, lineage, and deliverables into one study-centered experience.
01aCRFAnnotation
→
02SDTMSpecs + programming
→
03ADaMAnalysis data
→
04TLFsOutputs + QC
→
05ReadyReview package
WHAT IT DEMONSTRATES
A practical vision for clinical-data delivery.
Programming oversight
Monitor production programs, independent QC, execution status, and validation findings.
TLF development
Organize tables, listings, figures, shells, output QC, and sponsor style requirements.
End-to-end traceability
Connect outputs to analysis data, tabulation data, source fields, and documented decisions.
Readiness assessment
Surface conformance, open findings, completion metrics, and packaging status by study.
Reviewable reporting
Filter domain findings, inspect details, and export concise readiness summaries.
PROFESSIONAL PROFILE
Alpha S. Traoré
Principal Statistical Scientist Clinical Trials & Data Analytics
Statistical scientist and programmer with 9+ years of experience supporting Phase I–III clinical development and selected preclinical studies, with expertise across oncology, rare disease, and PK/PD. Expertise includes statistical programming, CDISC standards, TLF development, validation, traceability, and regulatory submissions. Develops reproducible analyses, analytical applications, and AI-enabled tools that strengthen data quality, streamline processes, and support confident decision-making.
SASRSDTMADaMTLFsTraceabilityValidationProcess Improvement
EXPLORE THE CONCEPT
See the workflow in action.
Navigate three synthetic studies, review module status, inspect validation findings, and export a demonstration readiness report.
Launch the Demo