Twelfth EDCTP Forum

15–20 Jun 2025 | Kigali, Rwanda

Scigenix (Pty) Ltd

Consulting firm

www.scigenix.ai/Pretoria, South Africa
3 profile visits

About

Scigenix is a data-driven Contract Research Organization (CRO) specializing in biostatistics (including pharmacokinetics), clinical data management, medical writing. Our mission is to support sponsors across the clinical development lifecycle by delivering high-quality, efficient, and compliant services grounded in scientific rigor and operational excellence.

Our team provides expert support aligned with international regulatory standards, ensuring confidence and consistency across every project. We integrate seamlessly into sponsor workflows, providing robust clinical trial support from protocol development and statistical analysis to regulatory documentation and submission readiness.

Scigenix was born out of nuvoteQ, a pioneering African healthtech company with a deep understanding of digital clinical research platforms. This foundation positions Scigenix uniquely at the intersection of clinical science and data science.

We offer advanced data science services tailored to the complexities of clinical research, including:

  • AI-enhanced data processing and automation

  • Machine learning-based risk assessment and dossier review

  • Custom analytics pipelines and visualizations using R and Python

  • Integration of open-source tools for flexibility and cost-efficiency

By leveraging the latest advancements in open-source machine learning and artificial intelligence, Scigenix fast-tracks data analysis and regulatory support tasks, empowering sponsors with faster, more accurate insights and reducing the time to key decisions. Our services also include the development of digital tools and platforms to improve efficiency in areas such as ethics committee and regulatory authority reviews.

Our data science solutions are applied in tightly controlled environments to ensure compliance, security, and reproducibility, ultimately leading to better data quality, reduced timelines, and optimized trial outcomes.

Scigenix is committed to innovation, collaboration, and integrity, working closely with our clients to bring new therapies to market with speed, precision, and confidence.

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Area of Activities

Academic and research institutionBiotechnology companyContract Research Organisation (CRO)Data science or digital health providerSME / MidCap / Start-up

Representatives

Shelly-Rae Smith

Chief Operating Officer

Scigenix (Pty) Ltd

Japie van Tonder

Chief Executive Officer

Scigenix (Pty) Ltd

Marketplace (4)

  • Service

    Clinical Data Management

    This service ensures seamless data collection, real-time validation, enhanced accuracy while maintaining compliance with standards.

    • Other services
    • Infectious diseases
    • Vaccines and therapeutics
    • Clinical research services
    • Maternal, child and community health
    • Non-communicable diseases linked to infectious diseases
    • Africa-Europe, Europe-Europe or Africa-Africa cooperation
    Author

    Shelly-Rae Smith

    Chief Operating Officer at Scigenix (Pty) Ltd

    Pretoria, South Africa

  • Service

    Biostatistics

    We offer expert biostatistics for clinical trials using R to deliver precise analysis, study design support, and regulatory-ready insights.

    • Other services
    • Infectious diseases
    • Vaccines and therapeutics
    • Clinical research services
    • Genomics and bioinformatics
    • Ethics and regulatory advisory
    • Maternal, child and community health
    • Genomics and/or bioinformatics support
    • Clinical trials and regulatory affairs
    • Non-communicable diseases linked to infectious diseases
    • Africa-Europe, Europe-Europe or Africa-Africa cooperation
    Author

    Shelly-Rae Smith

    Chief Operating Officer at Scigenix (Pty) Ltd

    Pretoria, South Africa

  • Service

    Medical Writing

    Comprehensive medical writing for clinical trials: protocols, reports, regulatory docs & manuscripts—clear, compliant, expert-led.

    • Other services
    • Infectious diseases
    • Vaccines and therapeutics
    • Clinical research services
    • Ethics and regulatory advisory
    • Maternal, child and community health
    • Clinical trials and regulatory affairs
    • Community engagement and social sciences
    • Non-communicable diseases linked to infectious diseases
    • Africa-Europe, Europe-Europe or Africa-Africa cooperation
    Author

    Shelly-Rae Smith

    Chief Operating Officer at Scigenix (Pty) Ltd

    Pretoria, South Africa

  • Service

    Data Science

    Data science at Scigenix boosts clinical trials with AI-driven insights, improving efficiency, accuracy, and patient outcomes.

    • Other services
    • Infectious diseases
    • Vaccines and therapeutics
    • Clinical research services
    • Genomics and bioinformatics
    • Laboratory and diagnostic services
    • Maternal, child and community health
    • Genomics and/or bioinformatics support
    • Clinical trials and regulatory affairs
    • Community engagement and social sciences
    • Health systems and implementation research
    • Non-communicable diseases linked to infectious diseases
    • Africa-Europe, Europe-Europe or Africa-Africa cooperation
    Author

    Shelly-Rae Smith

    Chief Operating Officer at Scigenix (Pty) Ltd

    Pretoria, South Africa