By M. Christine Morris, Executive Director, Life Sciences Solutions, TransPerfect
The COVID-19 pandemic has created obstacles for site monitoring in both ongoing and upcoming studies. This brave new world has inspired new recommendations by the FDA, EMA, and MHRA and led to an urgent push to explore and implement remote monitoring and oversight solutions. Sponsors need to know that activities are tracking toward successful trial conduct in accordance with the study protocol and other relevant regulations. They also need to ensure patient safety, with visibility into product/dosing administration and endpoint activities.
It is important to be able to catch and address any deviations from SOPs and protocols to remain compliant and mitigate any risks to patient safety, patient retention, data integrity, and regulatory inspection findings.