Cambridge, Mass. – September 25, 2026 -- Zifo has been named runner-up in the 2026 CDISC AI Innovation Challenge for TLFGenix, its AI-driven pipeline for generating clinical trial tables, figures, and listings, marking the company's second consecutive year of recognition in the competition.
Zifo's TLFGenix converts statistical analysis plans into traceable clinical outputs
TLFGenix was recognized under Use Case 3: AI-Driven Tables, Figures, and Listings Generation, one of three use cases in the global competition. The system uses six specialized agents to digitize Statistical Analysis Plans into a structured logical model, profile ADaM datasets, generate an ARS-aligned analysis specification, produce R driver scripts, execute them in a network-isolated sandbox, and check schema and output consistency. Statisticians approve the analysis specification before code generation and sign off on each individual output.
All models run within the enterprise boundary to secure clinical data
Zifo said all models operate on secure internal infrastructure, keeping clinical data inside the enterprise perimeter. A lineage graph links study objectives, endpoints, analyses, and results; when a Statistical Analysis Plan or approved specification changes, the system flags affected outputs for selective regeneration and reapproval. Each output includes a structured evidence record with a traceability matrix, execution logs, generated code, and approval history.
Competition submissions more than doubled to 50 entries from 30 organizations
The 2026 CDISC AI Innovation Challenge drew 50 submissions from 30 organizations and individual entrants, up from 22 submissions in the inaugural 2025 competition. Entries were evaluated on innovation and relevance, technical quality and feasibility, and standards integration, traceability, and impact. Zifo also submitted a separate AI-enabled approach for generating synthetic SDTM and ADaM datasets for automation testing.
Zifo built on its 2025 recognition for Unified Study Definitions Model work
In the inaugural 2025 challenge, Zifo was recognized for two solutions: one transforming clinical study protocols into structured, compliant Unified Study Definitions Model outputs with validation and traceability, and another linking protocols, case report forms, SDTM, ADaM, and TLF outputs within an interactive clinical data lineage environment.
Zifo plans to showcase TLFGenix at the CDISC US Interchange in Denver this October
Deepak Ananthan, Head of Clinical Services and AI Scaling at Zifo, said TLFGenix is part of the company's end-to-end AI Clinical workbench under its Practical AI initiative, combining AI, CDISC standards, and statistical programming practices while keeping human reviewers in control of final decisions. The 2026 Challenge is aligned with CDISC 360i, an initiative examining how standards, technology, and automation can support a connected, end-to-end clinical research data flow. Winning and runner-up solutions from the Challenge are expected to be presented at the 2026 CDISC US Interchange in Denver this October.