Shelly-Rae Smith

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.