Clinical study start-up includes many milestones starting with feasibility and ending with the enrollment of the first subject, with several key study activities in-between.
Conducting a feasibility study before a clinical trial is one of the keys to success that leads to the identification of the right sites for a successful study collaboration.
Regulatory submissions are critical milestones during clinical study start-up, and the outcome has a substantial impact on the timelines and conduct of the entire study.
Proper site management is an essential factor in executing a clinical trial successfully and we understand the central role that sites have on the outcome of a clinical study.
Adequate monitoring of clinical trials is imperative and guarantees the subjects’ rights and welfare, data quality, and regulatory compliance.