With the COVID-19 pandemic already impacting ongoing trials and likely to remain an active concern for at least 12 months, it remains critical for ongoing clinical trials to continue to assure the safety of trial participants, maintain compliance with good clinical practice and regulatory guidelines, and minimize the risks to trial integrity. In this webinar, you will hear about insights of the impact of COVID-19 on ongoing clinical trials, our interpretations of the recent regulatory guidance and statistical considerations for protocol amendments using a case study.
From this webinar you will learn:
• Insights derived from www.clinicaltrials.gov data to showcase the impact of COVID-19 on ongoing clinical trials by phase, recruitment status, sponsors and therapeutic area.
• Our interpretation and recommendations on the recent regulatory guidance’s for Sponsors and CROs
• The statistical considerations for protocol amendments in the areas recommended by regulatory authorities using a case study.