# About Scigenix — Leading African Clinical Research Innovation

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

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## About Scigenix

Scigenix is a next-generation Contract Research Organisation (CRO) specialising in biostatistics, clinical data management, medical writing, and AI-powered solutions. Led by CEO Japie van Tonder and COO Shelly-Rae Smith, the team of 22 experts has delivered 44 awarded projects with 15 completed successfully since founding in 2023.

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## Mission

> To accelerate and improve the quality of clinical drug development by turning data into valuable information, enabling faster, better, and more affordable clinical research for a more accessible healthcare world.

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## Vision

> To revolutionise the clinical research industry and become an effective advocate for the open-source community, showcasing the power of collaborative innovation in advancing healthcare.

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## Core Values

### Integrity & Transparency
Scigenix builds trust through scientific rigour, ethical conduct, and open communication. Regulatory compliance is a commitment, not just a requirement.

### Innovation with Purpose
Cutting-edge tools — from AI to real-time analytics — are used to solve real clinical challenges faster, smarter, and more reliably, not for novelty.

### Collaborative Excellence
Scigenix operates as an extension of the client's team, bringing expertise, responsiveness, and shared goals to every phase of the study lifecycle.

### Diversity & Impact
Founded in Africa and connected globally, Scigenix champions inclusion, local capacity building, and delivering clinical research that changes lives.

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## Leadership Team

| Name | Role |
|---|---|
| Japie van Tonder | CEO & Co-Founder |
| Shelly-Rae Smith | COO & Co-Founder |
| Dr Xan Swart | Associate Director, Biostatistics |
| Cornelia van Graan | Associate Director, Data Science |
| Rajeshwari Hanumanthappa | Associate Director, Data Management |

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## 6-Step Proven Methodology

Scigenix applies a comprehensive 6-step framework that transforms clinical trial processes from design to delivery.

### Step 1 — Study Design & Planning
Partners with scientific and medical teams to define clear objectives, optimise protocol structure, and determine statistically robust sample sizes.

### Step 2 — Data Capture & Management
Leverages validated eCRF platforms and ICH-compliant workflows to ensure accurate data entry, real-time validation, and rapid query resolution.

### Step 3 — Statistical Analysis & Programming
Dual-role biostatisticians/programmers translate SAPs into CDISC-compliant SDTM and ADaM datasets, generating TFLs with reproducible scripts in SAS, R, and Python.

### Step 4 — Medical Writing & Regulatory Alignment
Medical writers craft clear, submission-ready documents — from protocols and Investigator Brochures to CSRs and patient narratives — strictly adhering to ICH, GCP, FDA, and EMA guidelines.

### Step 5 — AI-Powered Insights & Optimisation
Proprietary AI tools provide automated safety flagging, regulatory checks, and predictive analytics, continuously monitoring trial data to uncover trends and mitigate risks in real time.

### Step 6 — Continuous Quality & Delivery
Integrated dashboards provide live visibility into progress, deviations, and deliverables — ensuring full audit readiness, on-time reporting, and confident decision-making.

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## Framework Results

| Metric | Result |
|---|---|
| Client Satisfaction | 98% |
| Regulatory Approval Rate | 100% |
| Time Reduction Achieved | 40% |
| Countries Served | 25+ |

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## Global Team Stats

| Stat | Detail |
|---|---|
| Continents represented | 5 (Africa, Europe, Asia, Americas, Oceania) |
| Expert professionals | 22 (scaled from 6 since 2023) |
| Projects awarded | 44 |
| Projects completed | 15 successfully since 2023 |
| Combined experience | 10+ years in clinical research and data science |

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## Core Expertise Areas

- Advanced Statistical Modelling
- Machine Learning & AI
- Regulatory Compliance (FDA, EMA, ICH)
- Clinical Data Management
- Biomarker Discovery
- Pharmacokinetic Analysis
- Medical Writing
- Open-Source Technologies (R, Python, Docker)

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## Innovation & African Excellence

Scigenix leverages the latest advances in AI and machine learning — carefully controlled for quality — to provide greater flexibility and access in clinical research solutions. As a proudly African-based organisation, Scigenix combines local innovation with global standards, contributing to the advancement of healthcare across all continents.