Sitilop has extensive experience in managing regulatory submissions and procedures of all necessary approvals that a study needs.

Our team can develop or advise on all documentation needed to expedite approvals through all the committees, as needed. Examples include preparing the application for ethical approval for clinical research trials, which includes documents such as the research protocol, the case report forms, and the informed consent documents. Sitilop also has extensive insight into preparing documents for specialised regulatory committees, such as ARSAC, as well as supporting or participating in meetings with regulatory bodies and can provide invaluable advice on responses to regulatory body reviews and requests.

Meet our team

Our vision is to drive healthcare forward, and accelerate this progress with our unique insights, and with our ability to reimagine and reinvent. Our team is constantly striving to innovate and find novel solutions to provide state-of-the-art services, in all aspects of clinical research, ranging from clinical activities, to the establishment of research protocols, regulatory and ethics submission, data analysis, using innovative and novel methodological approaches, and preparing materials for publication.