AI Innovation in TLF QC
AI-Driven TLF Validation
Transforming clinical reporting with intelligent automation for accuracy, efficiency, and regulatory compliance.
Page margins, borders, fonts, and alignment Pagination and blank page checks
Title and analysis set validation Footnote completeness, numbering, and symbols Treatment group and period labels
Required and excluded rows Parameter ordering and sorting rules “Not Coded” category handling
Subject counts vs ADaM datasets Percentages, denominators, and decimal precision Min/Max, P90, and descriptive block validation
Alignment across efficacy and safety tables Detection of repeated or missing summaries
Our tool understands shell intent, detecting issues that normally appear only during late-stage manual QC.
Up to 70% reduction in manual validation effort Fewer repeat QC comments Earlier detection of critical issues Consistent and accurate outputs Faster timelines without compromising quality
Biotech & Pharma Sponsors Faster submissions and reduced operational risk Enhanced oversight of outsourced deliverables
Increased throughput without additional headcount Competitive advantage and consistent quality
Less time on repetitive checks Focus on scientific review and complex derivations
Our tool supports regulatory inspections and audits by providing traceable, repeatable, and validated outputs, giving clients confidence in submission readiness.
Sponsors and partners report: Cleaner first-run outputs Fewer review cycles Standardized quality across studies and programs “Sigma-CHI’s AI-driven validation has set a new benchmark for efficiency and accuracy in our organization.”
Key Features:
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