# A Non-Destructive Methodological Framework for Modernizing Legacy Clinical Reporting Systems for AI-Driven Pharmacoinformatics: A SAS Case Study

arXiv: https://arxiv.org/abs/2605.13905 · HTML: https://mlsanity.com/paper/2605.13905/

## Key facts

- No citing papers in the map yet (data through 14 Oct 2026).
- Builds on 5 of its 42 references that are in the map.
- First posted on arXiv 13 May 2026.

## Builds on (most cited first, 5 of 5)

- [BioGPT: Generative Pre-trained Transformer for Biomedical Text Generation and Mining](https://mlsanity.com/paper/2210.10341/) (2022)
- [How is ChatGPT's behavior changing over time?](https://mlsanity.com/paper/2307.09009/) (2023)
- [Adapted Large Language Models Can Outperform Medical Experts in Clinical Text Summarization](https://mlsanity.com/paper/2309.07430/) (2023)
- [A Corpus with Multi-Level Annotations of Patients, Interventions and Outcomes to Support Language Processing for Medical Literature](https://mlsanity.com/paper/1806.04185/) (2018)
- [Using Large Language Models to Generate Clinical Trial Tables and Figures](https://mlsanity.com/paper/2409.12046/) (2024)

## Abstract (arXiv)

Drug development and pharmacovigilance are frequently bottlenecked by legacy clinical reporting pipelines. These monolithic systems encode regulatory-grade logic but resist AI integration by producing opaque output with no machine-readable intermediate layer. Existing modernization approaches force a choice between full rewrites and incremental refactoring that preserves structural barriers. We present a non-destructive methodological framework achieving AI-driven pharmacoinformatics readiness without altering legacy source code. A metadata layer--comprising a bridge map, a typed Intermediate Representation (IR), and an orchestrator--wraps existing components and re-exposes their outputs as structured data consumable by LLMs. It enables optional incremental consolidation, replacing selected legacy components with metadata-configured core routines while the remainder operates unchanged. Validated on a 558-component SAS reporting library (373,000 lines of code), the framework demonstrated immediate AI-readiness under coexistence mode, yielding machine-readable output. Where consolidation was elected, the modernized core achieved a 92% reduction in proprietary code. Parity validation on 14 report types from a Phase III study achieved cell-level parity of 80% or above on 11 reports (mean 82.7%, best 99.2%). A benchmark using CDISC CDISCPilot01 data achieved 100% parity across 5 reports. LLM experiments confirmed the IR enables automated pharmacovigilance, table summarization, and trial configuration generation. The framework offers a regulation-aware path to AI-integrated clinical reporting, accelerating drug development without interrupting regulatory submissions.