54gene is equalizing precision medicine by advancing healthcare through large scale discovery and translational research, advanced molecular diagnostics, and clinical programs for the benefit of Africans and the global population.
54gene’s Clinical Program Services (CPS) division is focused on partnering with global pharmaceutical and biotechnology companies, and multilateral health organizations to discover, develop, and commercialize new therapeutic and diagnostic products
that benefit Africans and the global population.
This goal is being achieved partly through extensive investment in building clinical research capacity in the region by enabling infrastructure, setting up required processes, and developing local talents' clinical research management expertise.
54gene's Clinical Research Training Academy contributes to this investment by offering a range of well-curated training courses on clinical research methodology. The courses cover every stage of the research process from designing a study, through study conduct, analyzing data, writing the report, and submitting for regulatory approval. The first course is the Clinical Research Associate Training Program.
The Clinical Research Associate (CRA) Training Program is an online interactive 10-course training designed for aspiring or entry-level CRA focused on developing and enhancing their knowledge of clinical research management, monitoring, and reporting.
The program offers practical training on the role, job function, and responsibilities of CRA as they relate to clinical study conduct. The ICH/GCP guidelines and applicable international and local regulations, and industry best practices are referenced and discussed. The following topics are covered during the training: Intro to Clinical Research, Good Clinical Practice, Good Documentation Practice, Study Monitoring, Informed Consent, and Data Privacy, Investigational Products Accountability, Safety Reporting, Data Quality Review & Verification, Sites Compliance and Inspection, Good Documentation Practice, and Protocol Writing and Amendment.