The impact of the COVID-19 pandemic on health systems and more broadly on society, make it necessary for sponsors to adjust how they manage clinical trials to ensure the rights, safety and wellbeing of trial participants.
The Food and Drug Administration (FDA) recently updated (4 December 2020) the “Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency”, to help sponsors in adjusting their management of trials and participants during the pandemic.
It provides specific advice on clinical trials to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.
RPN has successfully supported companies in clinical program development. Our team is able to provide innovative strategic solutions to optimize clinical development in support of the targeted label indication and, to gain regulatory approval.