# Scigenix — AI-Powered Clinical Research & Data Science Solutions

**URL:** https://www.scigenix.ai/  
**Last updated:** 2026-04-15

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## Tagline

*Smarter Data. Better Research.*

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## What is Scigenix?

Scigenix is a next-generation Contract Research Organisation (CRO) based in Pretoria, South Africa. Founded in 2023, Scigenix specialises in biostatistics, clinical data management, medical writing, and AI-powered solutions for clinical research. The company is part of the nuvoteQ Group and serves pharmaceutical companies, regulatory agencies, and academic research organisations across Africa and globally.

Scigenix accelerates clinical trial timelines, reduces costs, and improves data quality by combining deep domain expertise with cutting-edge AI and open-source technology.

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## Core Services

- **Biostatistics & Statistical Programming** — Statistical Analysis Plans (SAPs), CDISC-compliant datasets, Tables, Figures & Listings (TFLs), regulatory submission support
- **Clinical Data Management (CDM)** — eCRF design, data cleaning, validation, real-time analytics dashboards, database lock
- **Medical Writing** — Clinical Study Reports (CSRs), protocols, Investigator Brochures, ICH-compliant regulatory documents
- **PK & Exploratory Analysis** — Pharmacokinetic analysis, population PK modeling, bioequivalence studies, simulation studies
- **AI & Machine Learning Solutions** — Automated regulatory checks, data anonymisation, predictive analytics, AI-powered study monitoring

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## Proprietary AI Products

Scigenix has developed four proprietary AI tools built specifically for clinical research and regulatory workflows:

- **LEXI** — AI Risk Stratification Tool for regulatory agencies processing generic health product applications (HPAs)
- **Checkm8** — Automated Edit Check Tool for EDC database validation and User Acceptance Testing (UAT)
- **LewisLit** — Automated pharmacovigilance (PV) literature surveillance tool aligned with EMA GVP Module VI
- **Project J** — AI Document Searching System for searching, comparing, and analysing regulatory and technical documents

[View all products →](https://www.scigenix.ai/products)

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## Key Facts

- **Founded:** 2023
- **Headquarters:** Pretoria, Gauteng, South Africa
- **Team:** 22 expert professionals across 5 continents
- **Projects:** 44 awarded, 15 completed successfully since 2023
- **Client satisfaction:** 98%
- **Regulatory approval rate:** 100%
- **Time reduction achieved:** 40%
- **Countries served:** 25+
- **Parent group:** nuvoteQ Group

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## Why Scigenix?

- African-based, globally connected CRO with local regulatory knowledge
- Prioritises open-source technology (R, Python) for transparency and cost-efficiency
- End-to-end service from study design through to regulatory submission
- Proprietary AI tools built for clinical research — not generic AI repurposed for healthcare
- Compliance with FDA, EMA, ICH, and CDISC standards

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## Contact

**Website:** https://www.scigenix.ai/contact  
**Group:** nuvoteQ Group — [nuvoteQ.io](https://www.nuvoteq.io)