# Scigenix Services — Expert Clinical Research Services

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

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## Overview

Scigenix is a next-generation Contract Research Organisation (CRO) delivering specialised services in biostatistics, clinical data management, medical writing, and AI-powered solutions. The company combines deep domain expertise with cutting-edge technology to accelerate drug development timelines and ensure full regulatory compliance across FDA, EMA, and ICH standards.

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## Service 1: Biostatistics & Statistical Programming

Expert statistical design, analysis, and programming for clinical trials of all phases and sizes. Scigenix biostatisticians serve a dual role — combining statistical expertise with programming capability to deliver end-to-end analytical workflows.

**Key capabilities:**
- Statistical Analysis Plans (SAP) development
- Sample size calculations and power analysis
- CDISC-compliant SDTM and ADaM dataset programming
- Tables, Figures, and Listings (TFLs) generation in SAS, R, and Python
- Statistical reports and summaries
- Regulatory submission support (FDA, EMA, ICH)

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## Service 2: Clinical Data Management (CDM)

Comprehensive data management and processing services covering the full clinical trial data lifecycle — from eCRF design through to database lock and study closeout.

**Key capabilities:**
- Electronic Case Report Form (eCRF) design and build
- Data cleaning and processing workflows
- Data validation and quality assurance
- Safety listings and adverse event reporting
- Real-time analytics dashboards
- Database lock and study closeout procedures
- ICH-compliant workflows and audit trail support

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## Service 3: Medical Writing

Regulatory-grade medical writing aligned with ICH guidelines, GCP standards, FDA, and EMA requirements. Scigenix medical writers produce clear, submission-ready documents that minimise review cycles.

**Key capabilities:**
- Clinical Study Reports (CSRs)
- Study protocols and protocol amendments
- Investigator Brochures (IBs)
- Patient narratives and case studies
- Informed Consent Forms (ICFs)
- ICH guideline compliance throughout
- Regulatory submission documents

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## Service 4: PK & Exploratory Analysis

Pharmacokinetic (PK) analysis and modelling/simulation support to optimise clinical decision-making and trial design.

**Key capabilities:**
- Pharmacokinetic (PK) analysis
- Population PK modelling
- Bioequivalence studies
- Dose-response modelling
- Simulation studies for trial design optimisation
- Exposure-response analysis

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## Service 5: AI & Machine Learning Solutions

AI-powered tools and custom machine learning solutions designed specifically for clinical research workflows — not generic AI repurposed for healthcare.

**Key capabilities:**
- Automated regulatory compliance checks
- Data anonymisation and privacy protection (POPIA, GDPR)
- AI-powered study monitoring and risk-based monitoring support
- Predictive analytics for trial success probability
- Machine learning for biomarker discovery
- Automated report generation

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## Why Partner with Scigenix?

### Scientific Excellence
Deep expertise in clinical research methodologies combined with cutting-edge data science and AI innovation.

### Collaborative Partnership
Scigenix functions as a scientific partner from concept to market — an extension of the client's team across every phase of the study lifecycle.

### Precision & Innovation
Outside-the-box thinking combined with rigorous attention to detail, delivering breakthrough solutions without compromising accuracy or compliance.

### African Innovation, Global Standards
Proudly African-based with a global team spanning 5 continents. Local regulatory knowledge combined with FDA, EMA, and ICH compliance expertise.

### Open-Source Technology Commitment
Scigenix prioritises open-source technologies (R, Python, Docker) for transparency, reproducibility, and cost-effectiveness — reducing dependency on expensive proprietary tools.

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## Compliance Standards

- FDA 21 CFR Part 11
- EMA Annex 11
- ICH E6 (GCP)
- ICH E9 (Statistical Principles)
- CDISC (SDTM, ADaM)
- EMA GVP Module VI (Pharmacovigilance)
- POPIA (South African data protection)

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## Contact

Ready to accelerate your clinical research?  
**Contact Scigenix:** https://www.scigenix.ai/contact