# Scigenix Products — AI-Powered Clinical Research Tools **URL:** https://www.scigenix.ai/products **Last updated:** 2026-04-15 --- ## Overview Scigenix has developed four proprietary AI-powered software tools built specifically for clinical research and regulatory workflows. These tools are purpose-built for the challenges of clinical trials, pharmacovigilance, and regulatory submissions — not generic AI adapted to healthcare. --- ## Product 1: LEXI — AI Risk Stratification Tool **Category:** Regulatory Technology / AI **Primary users:** Regulatory agencies, health authorities reviewing generic medicine applications ### What is LEXI? LEXI is an AI-powered tool designed to streamline generic dossier reviews by extracting, interpreting, and summarising key content from health product applications (HPAs). It is purpose-built to help regulatory agencies in Africa and globally process generic medicine applications faster, more consistently, and at greater scale. ### The Problem LEXI Solves Generic health product applications (HPAs) create significant review backlogs for regulatory agencies. Traditional manual review processes are time-consuming, inconsistent, and struggle to efficiently prioritise applications based on risk levels — leading to delays in market access for generic medications. ### How LEXI Works LEXI integrates Retrieval-Augmented Generation (RAG) and Large Language Models (LLMs) to process 90% of generic HPAs efficiently. The AI system automatically extracts, interprets, and summarises key content while providing intelligent risk stratification to improve application prioritisation. ### Key Benefits - Processes 90% of generic HPAs efficiently - Improved prioritisation through intelligent risk stratification - Significant reduction in regulatory review times - Scalable processing to support backlog reduction - Maintains full regulatory compliance and safety standards ### Technology Stack RAG (Retrieval-Augmented Generation) · LLMs (Large Language Models) · Python · Natural Language Processing · Document Intelligence · AI/ML Frameworks · Cloud Infrastructure · API Integration ### Features & Capabilities - AI-powered content extraction from health product applications - Automated interpretation and summarisation of key HPA elements - Intelligent risk stratification and prioritisation algorithms - RAG-powered document processing for enhanced accuracy - LLM integration for contextual understanding - Scalable processing infrastructure for high-volume applications - Regulatory compliance validation and gap analysis - Standardised review templates and workflows --- ## Product 2: Checkm8 — Automated Edit Check Tool **Category:** Clinical Data Management / Test Automation **Primary users:** Clinical data managers, EDC administrators, CROs ### What is Checkm8? Checkm8 is a programmatic tool for automating database validation — specifically User Acceptance Testing (UAT) — in clinical research. Built entirely on open-source technologies, Checkm8 eliminates the manual effort and cost associated with traditional EDC validation. ### The Problem Checkm8 Solves Manual User Acceptance Testing (UAT) for electronic data capture (EDC) systems takes days or weeks to complete, is error-prone and inconsistent, and involves high licensing costs for proprietary validation tools. ### How Checkm8 Works Checkm8 uses open-source tools to programmatically validate EDC systems, automating the entire UAT process. The tool ensures database reliability and compliance while significantly reducing deployment time and costs through scalable, automated workflows. ### Key Benefits - Saves days or weeks of effort in EDC deployment - Reduces human errors for improved data accuracy - Lowers costs through open-source technology stack - Adapts to various EDC platforms for broad scalability ### Technology Stack Open-Source Tools · Python · Automated Testing Frameworks · EDC APIs · Database Validation · CI/CD Pipeline · Docker · Cloud Infrastructure ### Features & Capabilities - Automated database validation and UAT processes - Open-source technology stack for cost-effective deployment - Programmatic validation workflows and test automation - Multi-platform EDC system compatibility - Comprehensive error detection and reporting - Scalable infrastructure for studies of any size - Integration with popular clinical research platforms - Customisable validation rules and compliance checks --- ## Product 3: LewisLit — PV Literature Search Tool **Category:** Pharmacovigilance / Literature Surveillance **Primary users:** Pharmacovigilance teams, drug safety departments, regulatory affairs ### What is LewisLit? LewisLit is an automated literature surveillance tool for pharmacovigilance (PV), continuously scanning medical journals and databases to identify adverse events related to pharmaceutical products. It aligns with EMA GVP Module VI requirements. ### The Problem LewisLit Solves Pharmacovigilance teams must manually scan vast amounts of medical literature to identify potential adverse events. This is time-consuming, error-prone, and may miss critical safety signals — compromising patient safety and regulatory compliance. ### How LewisLit Works LewisLit employs advanced keyword-based matching and intelligent filtering across article titles, abstracts, and full texts to automatically flag relevant content for review. The system aligns with EMA GVP Module VI requirements, ensuring regulatory compliance while minimising manual workload. ### Key Benefits - Rapidly scans large volumes of medical and scientific literature - Minimises human error with standardised identification protocols - Enables real-time monitoring for early safety signal detection - Significantly reduces manual review time and resource requirements ### Technology Stack Natural Language Processing · Text Mining · PubMed API · Medical Literature Databases · Keyword Matching Algorithms · Real-time Monitoring · EMA GVP Standards · Automated Reporting ### Features & Capabilities - Automated literature surveillance across multiple journal databases - Advanced keyword-based matching and intelligent filtering - Full-text scanning of titles, abstracts, and complete articles - EMA GVP Module VI compliance and regulatory alignment - Real-time monitoring and alert systems - Customisable search parameters for specific pharmaceutical products - Standardised safety content identification protocols - Comprehensive reporting and audit trail capabilities --- ## Product 4: Project J — AI Document Searching System **Category:** Document Intelligence / Regulatory AI **Primary users:** Regulatory affairs teams, medical writers, clinical operations ### What is Project J? Project J is a smart, flexible AI tool for searching, comparing, and analysing content across multiple regulatory and technical documents simultaneously. It enables regulatory and technical teams to extract insights rapidly from complex document repositories. ### The Problem Project J Solves Regulatory and technical documents are complex, lengthy, and often scattered across multiple sources. Manual document analysis and comparison is extremely time-consuming and may miss critical connections or inconsistencies within large document repositories. ### How Project J Works Project J uses AI-powered document intelligence with user-selectable Large Language Models (LLMs) for tailored search and analysis tasks. The system enables advanced document comparison, content analysis, and rapid insight generation across multiple regulatory and technical documents simultaneously. ### Key Benefits - Advanced document comparison and search across multiple sources - Flexible LLM model selection for diverse analysis tasks - Accelerated insight generation from complex document repositories - Enhanced productivity for regulatory and technical teams ### Technology Stack Large Language Models (LLMs) · Document Intelligence · AI-Powered Search · Natural Language Processing · Document Comparison Algorithms · Multi-Modal AI · Cloud Infrastructure ### Features & Capabilities - AI-powered document search and content analysis - User-selectable LLMs for customised analysis tasks - Advanced document comparison and cross-referencing - Multi-document content correlation and insight generation - Flexible search parameters and query customisation - Regulatory document intelligence and compliance checking - Technical document analysis and summarisation - Intuitive interface for complex document workflows --- ## Request a Demo Interested in any of Scigenix's AI products? **Contact us:** https://www.scigenix.ai/contact